Explore regulatory affairs associate positions in 24 Regulatory Affairs Associate jobs in London
Associate Director Regulatory Affairs
Posted 1 day ago
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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
Associate Director, Regulatory Affairs, Oncology
Posted 28 days ago
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Job Description
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.
Regulatory Affairs Manager
Posted 1 day ago
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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 //
Regulatory Affairs Officer
Posted 1 day ago
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Job Description
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 Specialist
Posted 3 days ago
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Job Description
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.
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 //
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Regulatory Affairs Officer
Posted today
Job Viewed
Job Description
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
Head of Regulatory Affairs
Posted 1 day ago
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Job Description
Head of Regulatory Affairs
An outstanding opportunity has arisen within a leading, innovation-driven pharmaceutical company dedicated to delivering value-based, patient-centric healthcare solutions. As Head of Regulatory Affairs for the UK and Ireland, you will play a pivotal role on the Leadership Team, shaping and executing bold, forward-looking regulatory strategies across the entire pharmaceutical portfolio.
In this influential position, you will lead a highly skilled team of 12 professionals, driving innovative and sustainable regulatory solutions that enable timely and optimal product access. Working across early development, pre-launch, and lifecycle management, you will oversee a significant number of high-profile launches planned over the next three years. This is a rare opportunity for a strategic and visionary leader to shape the future of access in the UK and Ireland, ensuring that regulatory strategies not only enable market success but also deliver lasting value for patients.
Your approach will align closely with the company’s long-term objectives, therapeutic area priorities, and overarching mission to advance patient care, ultimately driving both regulatory excellence and sustainable business growth in a dynamic and evolving healthcare landscape.
Job Requirements:
- A degree in life sciences, health economics, epidemiology, or postgraduate qualification (e.g., MSc, PhD) in Health Economics, Market Access, or Public Health
- Long-term experience in, and demonstrated understanding of the pharmaceutical/biotech industry, managing prescription and innovative medicine
- Extensive experience focused on Market Access, Pricing, Contracting, Sales, Commerical and Marketing
- A comprehensive and in-depth understanding of the UK and Ireland healthcare systems, with expertise in navigating the complexities of Health Technology Assessment (HTA) processes, payer bodies, and reimbursement systems, including familiarity with key players, policy frameworks
- Proven track record of leading HTA submissions and executing competitive pricing models and commercial contracts with the NHS
- Comfortable building and adapting strategies across pre-launch, launch, and post-launch access stages, with proven experience in both pre- and post-launch phases
- Experience in Leadership and Team Management: Experience in managing direct reports (not just cross-functional leadership)
Education:
- Master’s degree or equivalent in Pharmacy or Life Sciences.
- Advanced qualifications such as a PhD, MD, PharmD, Specialised Pharmacist, or Master’s in Drug Regulatory Affairs are highly valued
- Vast experience in the life sciences and/or pharmaceutical industry, focused to Regulatory Affairs, with strong national experience for UK and Ireland
- Comprehensive understanding of the global drug development process, regulatory frameworks, and procedures covering product development, submission, and lifecycle management
- Proven experience in direct interactions with Health Authorities, supporting Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs), variations, renewals, and related submissions
- Several years of experience in leading international and cross-functional project teams, as well as direct leadership of Regulatory Affairs team leads and managers
- In-depth knowledge of local regulatory requirements, including the ability to interpret and apply complex legislation effectively
If you are an inspiring leader with a passion for innovation, we encourage you to apply early.
If you have the skills and experience for this opportunity and the ambition to take on this position, please contact Vicki for further details or email your CV today.
- By email:
- By phone: +44 (0) or +44 (0)
Regulatory Affairs Manager - CMC
Posted 1 day ago
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Job Description
Hobson Prior is seeking a Regulatory Affairs Manager - CMC to join a dynamic team in the biotech industry. In this role, you will focus on regulatory strategies and submissions related to Chemistry, Manufacturing, and Controls (CMC). This is an exciting opportunity to contribute to pre-clinical and early-phase projects in a rapidly evolving therapeutic area.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Lead the preparation of regulatory documents, including clinical trial applications (CTA), investigational new drug (IND) submissions, and genetically modified organism (GMO) applications.
- Collaborate with various teams to ensure manufacturing and analytical processes meet regulatory standards.
- Provide strategic input on regulatory pathways for complex biologics or biotech products.
Key Skills and Requirements:
- Strong understanding of regulatory processes, particularly in the EU and US.
- Experience with biologics, with a preference for candidates familiar with cell and gene therapy.
- Ability to work effectively across teams and adapt to a fast-paced environment.
For more information, please contact Syem Mannan .
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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