108 Director Of Regulatory Affairs jobs in the United Kingdom

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**POSITION OVERVIEW:**
You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic (TA) area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labelling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.
**RESPONSIBILITIES:**
+ As needed, represents Gilead in negotiations with regulatory authorities.
+ Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.
+ Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
+ May participate on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.
+ Defines the regulatory strategy for multiple Gilead products or projects.
+ Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.
+ Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, and routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.).
+ Oversees and approves the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.
+ Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.
+ Critically reviews documents for submission to regulatory authorities.
+ Provides matrix management and leadership to project teams.
+ Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
+ Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
**REQUIREMENTS:**
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
**Rest of World Education & Experience**
BA/BSC or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience leading a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.
**Knowledge & Other Requirements**
+ In-depth understanding of U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets.
+ In-depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results.
+ Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on its regulatory implications.
+ In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
+ Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.
+ Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
+ Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
+ Strong interpersonal skills and understanding of team dynamics.
+ Strong communication and organizational skills.
+ Strong negotiation and conflict resolution skills.
+ When needed, ability to travel.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**POSITION OVERVIEW:**
You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic (TA) area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labelling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.
**RESPONSIBILITIES:**
+ As needed, represents Gilead in negotiations with regulatory authorities.
+ Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.
+ Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
+ May participate on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.
+ Defines the regulatory strategy for multiple Gilead products or projects.
+ Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.
+ Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, and routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.).
+ Oversees and approves the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.
+ Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.
+ Critically reviews documents for submission to regulatory authorities.
+ Provides matrix management and leadership to project teams.
+ Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
+ Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
**REQUIREMENTS:**
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
**Rest of World Education & Experience**
BA/BSC or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience leading a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.
**Knowledge & Other Requirements**
+ In-depth understanding of U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets.
+ In-depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results.
+ Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on its regulatory implications.
+ In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
+ Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.
+ Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
+ Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
+ Strong interpersonal skills and understanding of team dynamics.
+ Strong communication and organizational skills.
+ Strong negotiation and conflict resolution skills.
+ When needed, ability to travel.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Our client, a rapidly expanding pharmaceutical company, is seeking an experienced and strategic Director of Regulatory Affairs to lead their regulatory strategy and compliance efforts. This hybrid role, based in Leeds, West Yorkshire, UK , is crucial for ensuring that all product development and commercial activities meet stringent global regulatory standards. You will be responsible for guiding the company through complex regulatory landscapes, securing approvals, and maintaining compliance throughout the product lifecycle. Key Responsibilities:

• Develop and execute comprehensive global regulatory affairs strategies for pharmaceutical products.
• Lead the preparation and submission of regulatory filings (e.g., INDs, NDAs, MAAs) to health authorities worldwide.
• Serve as the primary liaison with regulatory agencies, managing communications and interactions.
• Interpret and advise on current and emerging regulatory requirements and guidances.
• Oversee the regulatory aspects of product development, clinical trials, manufacturing, and post-market surveillance.
• Ensure adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
• Manage and mentor a team of regulatory affairs professionals.
• Conduct regulatory due diligence for potential partnerships and acquisitions.
• Develop and implement internal policies and procedures to ensure regulatory compliance.
• Contribute to strategic decision-making regarding product lifecycle management and market access.

Qualifications and Experience:

• Extensive experience in regulatory affairs within the pharmaceutical industry, with a proven track record of successful regulatory submissions and approvals.
• In-depth knowledge of global regulatory requirements (FDA, EMA, MHRA, etc.) for pharmaceutical products.
• Demonstrated success in leading regulatory strategy development and execution.
• Strong leadership, team management, and interpersonal skills.
• Excellent analytical, problem-solving, and strategic thinking abilities.
• Exceptional written and verbal communication skills, with the ability to negotiate effectively with regulatory agencies.
• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline; advanced degree (Pharm.D., Ph.D.) is preferred.
• Experience with lifecycle management and post-market regulatory activities.
• Familiarity with common regulatory submission software and databases.

This is a pivotal role for a seasoned regulatory affairs professional looking to make a significant impact within a growing pharmaceutical organization. If you possess deep regulatory expertise and strategic leadership capabilities, we encourage you to apply.

Associate Director UK&IE Regulatory Affairs
Date: Sep 7, 2025
Location:
Harlow, United Kingdom, CM20 2FB
Company: Teva Pharmaceuticals
Job Id: 62735
**Who we are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of innovative & generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The opportunity**
+ Responsible for developing the regulatory strategy, preparation and execution of regulatory submissions for Teva's innovative products
+ Represent Innovative Medicines Regulatory Affairs in local and global teams (Global Regulatory Strategy Team (GRST), project team, portfolio/commercial team, etc.) and provide regulatory filing strategy and guidance
+ Oversee and take ownership for Regulatory activities and strategies for Innovative medicines projects
+ Preparation and submission of new UK and IE Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products
+ To ensure high quality data and standards are used in support of all regulatory applications
+ Dossier Risk Assessment (Due Diligence)
+ To work proactively with internal and external stakeholders (e.g. MHRA and HPRA) to ensure work is prioritise in accordance with business needs
+ Assessment of business development opportunities from regulatory perspective.
+ Mentoring and training of other regulatory professionals as required
**How you'll spend your day**
+ Portfolio of products:Responsibility of UK/IE assigned Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products.
+ Ensure thatcross-functional activitiesto support submissions are in compliance with regulatory requirements, to achieve timely submissions. Identify gaps and propose/support solutions to address them that are consistent with regulatory requirements. Initiation and/or participation in teleconferences and/or meetings related to the topic/project (to clarify issues, solve issues, discuss changes and strategy, check timelines and availability of documents, etc.).
+ Regulatory support to R&D:Ensure R&D receive the regulatory guidance necessary to ensure that responses are submitted on time and that content is aligned with MHRA/HPRA data requirements.
+ Provideregulatory supportthroughout product development to approval for local co-development initiatives and local in-license of new products
+ Strategy:Formulate regulatory strategies for products within the team for new submissions and post approval changes. Actively participate in gross-functional teams and contribute to Teva's overall strategy through identification, development and implementation of business improvement initiatives.
+ Oversee the development and maintenance ofRA documentation, policies and proceduresto implement local regulatory policies and procedures to assure compliance with Teva operating principles, SOP's and other in house requirements.
+ Stakeholder management: Build strong working relationships with key interfaces and provide regulatory support for interfaces where requested. Promote cross-functional working across the PV, medical, commercial, quality and supply chain teams.
+ Marketing Authorisation Applications: Deliver new submission work plan commitments for all allocated products. Ensure that regulatory approvals are secured in a timely manner for on-time launches.
+ Post Approval support: Ensure that regulatory post approval regulatory obligations are fulfilled to ensure compliance, deliver on time launches and maintain continuity of supply.
+ External interactions: Lead or participate in preparations for health authority meetings and effectively chair discussions. Where requested, contribute to industry association projects and participate in regulatory professional body activities on request.
+ Regulatory Intelligence: Maintain an in-depth understanding of legislative requirements, MHRA regulatory guidance and changes to the external environment that could affect the UK/IE market.
+ Other:Other duties as required by the direction of the Director of Regulatory Affairs regarding project leadership/management, strategic planning, business process redesign and commercial implementation.
**Your experience and qualifications**
**Do you have?**
+ BSc/MSc in pharmacy, chemistry or Life Sciences
+ A strong understanding and knowledge of local regulatory requirements, and also actual experience of leading regulatory activities in the United Kingdom (e.g. scientific advice, MAA submissions to MHRA, NICE technology appraisal)
+ Substantial regulatory new submission and post approval submissions experience for a wide range of dosage forms and legal basis, especially for new chemical entities, but also generics, devices and OTC products.
+ Regulatory strategy development with a focus on bringing innovative solutions to project teams and health authorities.
+ Demonstrated experience of contact and relationship with health authorities, preferably with MHRA and HPRA.
+ A good knowledge and experience in CTAs, paediatric investigation plans and orphan designations.
+ Experience in leading and chairing Scientific Advice meetings.
+ Management or mentoring of team members including accountability for projects and regulatory strategy, ownership of team structure and line management of team members.
+ Good leadership, project management and communication skills as well as managerial capability, with excellent attention to detail.
**Are you?**
+ Able to strategically apply knowledge across a portfolio of products
+ Excellent oral and written communication skills
+ Negotiator
+ Analytical
+ Good trainer who loves coaching
+ Able to monitor and communicate change in the regulatory environment
+ Able to work effectively in a global matrix
**Enjoy a more rewarding choice**
We support our people through every stage of their journey with us. Our _flexible reward platform_ puts you in control, empowering you to tailor your benefits to fit your lifestyle, priorities, and what matters most to you. With _25 days of annual leave_ that grows with your service, the flexibility to purchase additional days, and _two dedicated volunteering days each year_ , your time off is truly yours to enjoy, recharge, and give back. We prioritise your health with _private medical insurance, life assurance, critical illness cover, and income protection._
Whether you're growing your family or pursuing new adventures, our _enhanced maternity and paternity leave, sabbaticals, and hybrid working policies_ are here to support you through life's most meaningful moments. Financial wellbeing matters too, which is why we offer an _enhanced pension scheme, access to a discount store, and free financial coaching through Bippit._
To help you grow with confidence, we offer a structured _training and development programme_ tailored to your role and department, equipping you with the tools, knowledge, and support you need to thrive.
**Reports To**
Director Regulatory Affairs UK&IE
**Already Working @TEVA?**
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site ( internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.#TJ
EOE including disability/veteran

_About the job_
**_Job Purpose:_**
+ To obtain, manage and maintain product Marketing Authorisations in line with business goals and legal requirements. To conduct associated regulatory activities for the specified markets under the guidance and supervision of line management, and to contribute to the implementation and leading of projects.We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**Main responsibilities:**
+ Co-ordinates, prepares, submits and follows up registration applications to the UK and /or Irish regulatory authorities, expeditiously and to high standards, to ensure that marketing authorisations are obtained and maintained in line with the company's plans and goals.
+ Prepares and submits responses to enquiries and deficiencies noted by regulatory authorities in connection with applications filed, under supervision, to facilitate the earliest possible approval.
+ Prepares and reviews labelling, package leaflets and summaries of product characteristics etc. to ensure compliance with current legislation and registered particulars, and takes action, as agreed with supervisor, to secure regulatory approval where necessary.
+ Supports the launch of new products and life cycle management of the existing portfolio.
+ In order to achieve success, it is essential that the Regulatory Officer:
+ Ensures that all data supplied to the regulatory authorities are of the highest quality possible in terms of both content and presentation, whilst meeting agreed deadlines.
+ Works proactively with members of the Global Business Units and other Global functions to ensure project needs are met compliantly within agreed timelines
+ Assists management in providing strategic input into development of registration strategies and operating planning processes for commercialisation of products, both locally and in conjunction with GRA.
+ Contributes to the effective running of departmental and cross functional project teams
+ Supports activities to obtain, manage and maintain product Marketing Authorisations in line with business goals and legal requirements. Conducts associated regulatory activities for the specified markets under the guidance and supervision of line management, and contributes to the implementation and leading of projects.
+ Provides regulatory input, with support, to commercial strategic and operating planning process.
**_About you_**
+ At least 1 year experience working in Regulatory Affairs, preferably up to 2 years.
+ An understanding of lifecycle maintenance for pharmaceutical products, particularly variations.
+ Proven project management skills.
+ Biologicals and/or Vaccines experience desirable.
+ Life sciences or chemistry degree or equivalent professional qualification or proven relevant experience within the regulatory environment.
+ Proven familiarity with the pharmaceutical research and development process with ability to integrate scientific information from a variety of disciplines.
+ Ability to work across a variety of therapeutic areas with new and/or established medicines with the capability to represent Regulatory at brand meetings, with support from management.
+ An awareness of EU regulatory procedures for marketing authorisations and submission to regulatory authorities.
+ An awareness of lifecycle maintenance for pharmaceutical products, including variations and renewals.
+ An awareness of ABPI and IPHA code, promotional and non-promotional materials and PI.
+ Awareness of product quality and Good Manufacturing Practice (GMP) requirements.
+ An understanding of CMC changes and the ability to identify changes to registered details.
+ An understanding of the Common Technical Document (CTD) and pharmaceutical dossier structure.
+ Administratively well organised, demonstrating attention to detail, strong written and oral communication skills. Able to communicate effectively and efficiently with other functional departments in the business.
**_Why choose us?_**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
+ Join us in shaping the future of respiratory care and making a difference in the lives of patients across the NHS.
+ If you have a disability and require adjustments for the interview process, please email us at We are dedicated to ensuring an inclusive and supportive experience for all applicants.

**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (

**Regulatory Affairs Manager**
**Abbott Diabetes Care**
**Witney, Oxfordshire**
**Competitive Salary + Excellent Benefits**
Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. Our product portfolio includes Freestyle Libre, a recently launched system that is revolutionising how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people's lives.
We currently have an opportunity for a Regulatory Affairs Manager to join our team, based in Oxfordshire, supporting the significant manufacturing capacity expansion underway at the Witney site plus other Operational and R&D projects.
**Primary Job Function**
You will set the EU Regulatory Strategy that is well-defined and effective. The strategy sets out innovative solutions to Regulatory Approval so that plans can be set out.
You will oversee the Project Management of regulatory projects, integrating with the US and OUS Regulatory organisation, the R&D organisation and other key functional groups.
**Core Job Responsibilities**
+ Ensures maintenance of strong communication and working relationships with the Alameda RA group and other RA teams globally.
+ Ensures maintenance of strong communication and working relationships with the Clinical Affairs organisation, R&D Development groups and US Project Management.
+ Supports the interface and guidance of any external auditors such as FDA and ISO assessors reviewing Technical Files.
+ Provides leadership on Notified Body strategy and regional/global planning of product registration.
+ Responsible for defining the regulatory strategy for product approvals in EU and region.
+ Each new development project (product) requires a regulatory strategy to be created and maintained.
+ Responsible for supporting RA compliance with site EHS policy and procedures.
+ Responsible for maintaining the effectiveness of the Quality System at the site in accordance with Abbott Corporate requirements and applicable regulations.
+ Excellent communication / negotiating skills for discussions with Notified Bodies and Competent Authorities etc.
**Position Accountability / Scope**
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
+ This position must ensure that the products are registered in the countries as appropriate and ensure compliance to QS Regulations, ISO regulations, etc.
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
**Minimum** **Education**
+ Minimum of a Bachelor's degree or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.
**Minimum** **Experience/Training Required**
+ Minimum of a bachelor's degree is required to ensure that the jobholder has sufficient technical knowledge to effectively and confidently be the Regulatory Affairs Project Mgr in the EMEA region.
+ Knowledge of regulatory requirements for ISO 13485, EMC, MDD (93/42/EEC), IVDD (98/79/EC), MDR 2017/745 & IVDR 2017/756, and FDA Quality Systems Regulations is essential.
+ Experience within a medical or healthcare manufacturing industry in a regulatory role. The position requires an understanding of the needs of the customer and knowledge of regulations and standards affecting IVDs and MDDs, the regulatory bodies and country regulations that govern ADC products to enable the jobholder to interpret and apply regulations and standards to products and processes.
+ You need to have excellent written and oral communication skills necessary to be able to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.
+ You need to have the depth of Regulatory knowledge to be able to define a Regulatory Strategy that is well defined and effective. Additionally, the depth of experience is required to ensure that innovative solutions to Regulatory Approval paths can be set out.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Biosystems, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Leica Biosystems, we're not just shaping the future of cancer diagnostics - we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business System ( which makes everything possible.
The Principal, Regulatory Affairs is responsible for developing and executing global regulatory strategies for high-complexity diagnostics including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology space. This individual will partner with internal teams and external stakeholders to enable successful global commercialization of innovative technologies (including but not limited to IDEs; Performance Study Applications; IVDR TF in EU and 510k and PMA in USA).
This position reports to the Senior Manager, Regulatory Affairs and is part of the Global Regulatory Affairs Team located in Newcastle, UK and will be an on-site role.
In this role, you will have the opportunity to:
+ Serve as the Lead Regulatory Affairs representative on new product development teams for both IVD medical device and RUO products.
+ Develop and execute global regulatory strategies, including FDA 510(k), Pre-Submissions, Health Canada filings, and IVDR Technical File authoring.
+ Provide regulatory guidance on product labelling, marketing materials, and product changes to ensure compliance.
+ Collaborate cross-functionally with global teams and represent Regulatory Affairs on project teams, contributing regulatory intelligence and strategic input.
+ Engage and negotiate with global regulatory agencies to achieve product clearance/approval, while staying current on evolving regulations, guidance, and competitive landscapes.
+ Share regulatory expertise across Leica and Danaher sites, contribute to cross-functional initiatives, and apply Danaher Business System (DBS) tools to drive continuous improvement and measurable results.
The essential requirements of the job include:
+ Bachelor's degree in science or engineering or equivalent experience.
+ Extensive experience with regulatory strategy and submissions for high-complexity diagnostic products in a global market. Experience supporting clinical trials a plus.
+ In-depth working knowledge of FDA, Health Canada and EU regulatory requirements for IVD devices.
+ Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including IVDR, 510k, PMA, and Health Canada submissions.
+ Strong analytical mindset with a continuous drive for regulatory intelligence and minimal supervision needed.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel - list specifics 15% travel, overnight, within territory or locations
It would be a plus if you also possess previous experience in:
+ Applies deep regulatory expertise to the development and global commercialization of complex, high-risk products, balancing short-term problem-solving with long-term strategic outcomes and risk-benefit analysis.
+ Works effectively in matrixed and cross-cultural environments, driving timely decisions, issue resolution, and resource agility while setting high expectations and modeling accountability and integrity.
+ Communicates complex and sensitive information clearly across diverse audiences; builds consensus, demonstrates strong writing and documentation skills, and uses sound judgment to influence and lead through change.
Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .

Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA.
This position is part of Medical Regulatory Affairs located in Portsmouth, UK and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
+ Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices.
+ Submit Technical Documentation to Notified Bodies for review and approval.
+ Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls.
+ Support medical device Regulatory Intelligence process and customer requests.
+ Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
+ Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.
Who you are:
+ You have a Life Sciences degree or equivalent.
+ You have at least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
+ Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971.
+ Experience with Quality Management System documentation.
+ Ability to communicate effectively across all departments and functions
+ Good attention to detail.
+ Have excellent English oral and written communication.
+ The ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel required at 10% or less within the EMEA region.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .

Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA.
This position is part of Medical Regulatory Affairs located in Portsmouth, UK and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
+ Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices.
+ Submit Technical Documentation to Notified Bodies for review and approval.
+ Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls.
+ Support medical device Regulatory Intelligence process and customer requests.
+ Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
+ Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.
Who you are:
+ You have a Life Sciences degree or equivalent.
+ You have at least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
+ Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971.
+ Experience with Quality Management System documentation.
+ Ability to communicate effectively across all departments and functions
+ Good attention to detail.
+ Have excellent English oral and written communication.
+ The ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel required at 10% or less within the EMEA region.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .