30 Regulatory Affairs Director jobs in London
Associate Director Regulatory Affairs
Posted today
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Job title: Associate Director, Regulatory Affairs
A Pharmaceutical business in London is looking for an Associate Director, Regulatory Affairs to join their team. In this role you will hold either a EU Regulatory Lead role or Global Regulatory Lead role depending on the portfolio of products assigned.
Responsibilities:
- Working together with multi-functional / geographical teams and other internal stakeholders to ensure that projects meet all key objectives and are delivered on time.
- Develop Regulatory Strategies for any new submissions as well as identifying risks.
- Contribute to the preparation of briefing packages for Scientific Advice and orphan drug designations.
- Participate during the interactions with Health Authorities.
Requirements:
- Substantial experience within Regulatory affairs and pharmaceutical industry.
- Extensive experience in the submission of new products.
- Experience working with new MA's.
- Experience interacting with EU/UK regulatory authorities.
Salary and benefits:
A highly competitive salary and wider benefits scheme is on offer.
To apply for this position or hear further details then please contact Freddie Hill via
Associate Director Regulatory Affairs
Posted today
Job Viewed
Job Description
Job title: Associate Director, Regulatory Affairs
A Pharmaceutical business in London is looking for an Associate Director, Regulatory Affairs to join their team. In this role you will hold either a EU Regulatory Lead role or Global Regulatory Lead role depending on the portfolio of products assigned.
Responsibilities:
- Working together with multi-functional / geographical teams and other internal stakeholders to ensure that projects meet all key objectives and are delivered on time.
- Develop Regulatory Strategies for any new submissions as well as identifying risks.
- Contribute to the preparation of briefing packages for Scientific Advice and orphan drug designations.
- Participate during the interactions with Health Authorities.
Requirements:
- Substantial experience within Regulatory affairs and pharmaceutical industry.
- Extensive experience in the submission of new products.
- Experience working with new MA's.
- Experience interacting with EU/UK regulatory authorities.
Salary and benefits:
A highly competitive salary and wider benefits scheme is on offer.
To apply for this position or hear further details then please contact Freddie Hill via -partners.co.uk
Director, Regulatory Affairs, Pre-Market
Posted 22 days ago
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Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.
**Job Description**
**Roles and Responsibilities**
+ **Leadership & Strategy**
+ Lead and develop the European Regulatory Affairs team, fostering a high-performance and collaborative culture.
+ Define and execute regulatory strategies aligned with GE HealthCare's global objectives.
+ Represent Regulatory Affairs in cross-functional leadership forums and strategic initiatives.
+ **Regulatory Compliance**
+ Ensure compliance with EU MDR and other applicable European regulations.
+ Act as PRRC under MDR, ensuring product conformity and regulatory documentation integrity.
+ Oversee regulatory submissions, CE marking processes, and interactions with Notified Bodies and Competent Authorities.
+ **Operational Excellence**
+ Drive continuous improvement in regulatory processes and systems.
+ Monitor regulatory changes and assess impact on GE HealthCare's product portfolio.
+ Support audits, inspections, and regulatory due diligence activities.
+ **Stakeholder Engagement**
+ Collaborate with Quality, Legal, Commercial, and Product teams to ensure regulatory alignment.
+ Provide expert guidance and training on European regulatory requirements.
+ Represent GE HealthCare in industry associations and regulatory forums as needed.
**Required Qualifications**
+ Bachelor's or Master's degree in Life Sciences, Engineering, or related field.
+ Minimum 10 years of experience in Regulatory Affairs, with significant exposure to European medical device regulations.
+ Proven leadership experience, including team management and strategic planning.
+ Fluent in German and English (written and spoken).
+ Must be based in the European Union and meet the qualifications to act as PRRC under MDR.
+ Strong knowledge of EU MDR, IVDR, and relevant guidance documents.
+ Excellent communication, negotiation, and stakeholder management skills.
**Desired Characteristics**
+ Experience working in a global or matrixed organization.
+ Familiarity with digital health technologies and software as a medical device (SaMD).
+ Ability to influence and lead through change.
#LI-AO1
#LI-Hybrid
**Additional Information**
**Relocation Assistance Provided:** No
Associate Director, Regulatory Affairs, Oncology
Posted 28 days ago
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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.
Legal Compliance Manager
Posted today
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Legal Compliance Manager - Media sector
£70,000 - £80,000 dependent upon experience
London, 2 days a week in the office
Audit & Risk Recruitment are delighted to be partnering with a very well known group in the media sector. Our client is a large, highly complex organisation with a challenging Risk profile. This role reports to the Head of Risk Management and will be responsible for managing risks associated with Compliance across the whole business, as well as preparing quality, timely reports for a selection of governance committees.
Key tasks include:
- Taking accountability for compliance risk deliverables and outputs, including the preparation of compliance reports
- Work with stakeholders to identify compliance risk areas and vulnerability. Monitor compliance and assurance activity, and create remediation plans as necessary.
- Draft Executive-level summaries for senior stakeholders detailing compliance issues, findings and outcomes
- Provide insight and analysis to Board-level executives
- Drive a culture of compliance and integrity across the organisation.
- Become an expert in compliance-related risks and activities for the organisation, including staying on top of developments and trends and adapting to business strategy
You will be a legal compliance expert with plenty of in-house experience, preferably gained from the commercial or industrial sectors. You must have a detailed understanding of compliance risk management programmes and what 'good' looks like. You will need excellent written and oral communication skills.
Legal Compliance Manager
Posted today
Job Viewed
Job Description
Legal Compliance Manager - Media sector
£70,000 - £80,000 dependent upon experience
London, 2 days a week in the office
Audit & Risk Recruitment are delighted to be partnering with a very well known group in the media sector. Our client is a large, highly complex organisation with a challenging Risk profile. This role reports to the Head of Risk Management and will be responsible for managing risks associated with Compliance across the whole business, as well as preparing quality, timely reports for a selection of governance committees.
Key tasks include:
- Taking accountability for compliance risk deliverables and outputs, including the preparation of compliance reports
- Work with stakeholders to identify compliance risk areas and vulnerability. Monitor compliance and assurance activity, and create remediation plans as necessary.
- Draft Executive-level summaries for senior stakeholders detailing compliance issues, findings and outcomes
- Provide insight and analysis to Board-level executives
- Drive a culture of compliance and integrity across the organisation.
- Become an expert in compliance-related risks and activities for the organisation, including staying on top of developments and trends and adapting to business strategy
You will be a legal compliance expert with plenty of in-house experience, preferably gained from the commercial or industrial sectors. You must have a detailed understanding of compliance risk management programmes and what 'good' looks like. You will need excellent written and oral communication skills.
Regulatory Affairs Specialist
Posted 4 days ago
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Join a leading innovator in the chemical sector, driving compliance and sustainability across global markets. We’re seeking a detail-oriented Regulatory Affairs Specialist with a strong foundation in chemical regulations to ensure our products meet all legal and safety standards.
The Role
As a Regulatory Affairs Specialist , you will play a pivotal role in managing product registrations, preparing regulatory documentation, and maintaining compliance with national and international chemical legislation (REACH, CLP, SDS, etc.). You’ll collaborate with R&D, Quality, and Commercial teams to support new product introductions and ensure continuous regulatory alignment.
Key Responsibilities
- Prepare, review, and submit product registration dossiers and notifications.
- Maintain up-to-date knowledge of chemical regulations and compliance requirements.
- Support Safety Data Sheet (SDS) authoring and classification activities.
- Liaise with regulatory authorities and third-party consultants.
- Contribute to internal audits and compliance projects.
- Provide regulatory guidance for product development and market access.
The requirements
- Bachelor’s degree (or higher) in Chemistry, Toxicology, Environmental Science, or a related field.
- Minimum 2 years’ experience in regulatory affairs within the chemical, pharmaceutical, nutraceutical and/or food industries .
- Working knowledge of REACH, CLP, and GHS regulations.
- Strong analytical, organizational, and communication skills.
- Ability to manage multiple projects and deadlines effectively.
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Regulatory Affairs Manager
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Walker Cole are recruiting for a Regulatory Affairs Manager position for an early stage ATMP pharmaceutical business. This is an exciting opportunity for a junior professional to grow and develop within the ATMP space from a range of skills and experience within the team.
A Regulatory Manager will bring:
- Regulatory CMC experience at early-stage development in ATMP and/or biological products
- A drive and willingness to learn and grow within this space.
- Ability to work well within a team, cross functionally and independently
As a Regulatory Manager you will:
- Work within an expert team on Regulatory CMC
- Support in CMC gap analysis, write guidance document and IMAPs
- IMPD, IND submissions and pre-clinical activities.
Early-Stage // Development // Pre-clinical // Regulatory CMC // Regulatory Affairs // Biologics // ATMP // Advanced Therapy //
Regulatory Affairs Officer
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Overall Job Purpose:
The Regulatory Affairs (RA) Officer is primarily responsible for ensuring the appropriate licensing, marketing and legal compliance of Sun Pharma’s pharmaceutical and medical products in order to control the safety and efficacy of these products. The RA Officer combines scientific, legal and business knowledge to ensure Sun Pharma’s products meet the required legislation. He/she is responsible for the approval and registration of Sun Pharma’s products in UK market.
Responsibilities:
- Is responsible for liaising with internal and external partners to receive the necessary documents in a timely manner, e.g. internally with R&D, RA and art work departments, externally with translations services and consultants for e.g. Package Leaflet User test reports.
- Is responsible for the preparation of SmPC, labelling and PILs texts according to the Quality Review of Documents (QRD) format.
- Is responsible for text verification of the product information documents.
- Is responsible for proof reading of art work of packaging materials.
- Ensure dossier technical content is optimal and aligned with UK Regulatory data requirements for new UK Marketing Authorisation Applications
- Maintains the life cycle management of the dossiers or the approved marketing authorizations as required by submitting variations/notifications/PSURs and renewals.
- Liaises with regulatory colleagues in the different country offices, corporate groups and competent authorities (MHRA) and third parties on regulatory issues.
- Works closely together with internal customers such as Research & Development, Artwork, Pharmacovigilance, Quality Assurance, Logistics, Finance, Business Development, Sales.
- Maintains RA archives (electronically).
- Keeps the Regulatory Information correct and accessible for other stakeholders.
- Being able to work with the required IT standards, like eCTD, XEVMPD
- Being able to work with the corporate IT systems like AMS, Trackwise, eDMS, eLMS, OneHR
- Determines and writes standard operating procedures.
Qualifications:
- Bachelor or Master Degree (preferably in Life Sciences, Languages or Law)
- 2-5 years of experience in pharma
- Rounded knowledge of the UK and EU Regulatory Framework (directives, regulations, guidelines)
- Some understanding of the drug development process
- Able to comply with company standard operating procedures
- Good verbal and written communication skills in English
- Good IT skills including familiarity with Microsoft Office packages and specific packages/portals such as eCTD software, XEVMPD software, TVT, CESP, EMA gateway, MHRA and CBG portal.
- Excellent attention to detail
- Good time management skills
- Good organization and project management skills
- Good interpersonal and team working skills
- Presentation skills and experience of delivering training
Regulatory Affairs Manager
Posted today
Job Viewed
Job Description
Walker Cole are recruiting for a Regulatory Affairs Manager position for an early stage ATMP pharmaceutical business. This is an exciting opportunity for a junior professional to grow and develop within the ATMP space from a range of skills and experience within the team.
A Regulatory Manager will bring:
- Regulatory CMC experience at early-stage development in ATMP and/or biological products
- A drive and willingness to learn and grow within this space.
- Ability to work well within a team, cross functionally and independently
As a Regulatory Manager you will:
- Work within an expert team on Regulatory CMC
- Support in CMC gap analysis, write guidance document and IMAPs
- IMPD, IND submissions and pre-clinical activities.
Early-Stage // Development // Pre-clinical // Regulatory CMC // Regulatory Affairs // Biologics // ATMP // Advanced Therapy //