Latest regulatory affairs Jobs

Regulatory Affairs Manager, Oncology Therapeutic Group, Global Regulatory Affairs

This role involves developing and executing global and regional regulatory strategies for oncology products across their lifecycle, ensuring compliance and optimal labeling. The manager will collaborate with cross-functional teams and regulatory authorities to support submissions and approvals, leveraging regulatory intelligence to inform decision-making. The position emphasizes strategic planning, stakeholder engagement, and innovation within a patient-focused biopharma environment.

GSK Stevenage, United Kingdom

Hybrid Permanent

Regulatory Affairs Manager, Oncology Therapeutic Group, Global Regulatory Affairs

Develop and execute global regulatory strategies for oncology assets, ensuring compliance and optimal labeling across markets. Collaborate with cross-functional teams and regulatory authorities to support product development and approvals. Drive innovation and process improvements within the regulatory lifecycle.

GSK United Kingdom €98,250 – €163,750 pa

Regulatory Affairs Specialist - Medical Devices - Cambridge

This role involves providing regulatory expertise to guide product development across medical and non-medical technologies, ensuring compliance with international standards such as ISO 13485, FDA 21 CFR 820, and ISO 9001. The specialist will work embedded within project teams, interpreting evolving regulations, supporting quality systems, and enabling innovation while maintaining regulatory alignment throughout the product lifecycle.

Newton Colmore Cambridge, Cambridgeshire, United Kingdom

On-site Permanent

Regulatory Affairs Specialist

This role involves maintaining regulatory compliance for medical devices across the UK and EU, with responsibilities including managing product registrations, technical documentation, and post-market surveillance activities. The specialist will ensure ongoing adherence to standards like MDR, MDD, and UKCA within an SME manufacturing environment. The position supports compliance through meticulous documentation control and regulatory monitoring.

ProTech Recruitment Ltd Hertford, Hertfordshire, United Kingdom £35,000 – £40,000 pa

Hybrid Permanent Part-time

Associate Director, CMC Regulatory Affairs, International

This role involves leading CMC regulatory strategies for international submissions, including IND/CTA/BLA/MAA filings, with a focus on mRNA-based medicines. The individual will guide global regulatory compliance, interact with health authorities, and support quality and manufacturing teams across therapeutic areas like vaccines, oncology, and rare diseases. It requires deep expertise in biologics CMC regulations and a proactive approach to navigating complex regulatory landscapes.

Moderna London, United Kingdom

On-site Permanent

Director, Regulatory Affairs

Lead global regulatory strategy and execution for drug development programs, ensuring compliance across jurisdictions including the US, EU, and UK. Collaborate with cross-functional teams to prepare and manage regulatory submissions such as INDs, NDAs, and orphan drug designations. Provide strategic guidance on regulatory risks and lifecycle management, while engaging with health authorities and shaping regulatory science in the context of AI-driven drug discovery.

Recursion North Tyneside, NE29 8EP, United Kingdom £207,500 – £280,720 pa

Remote Permanent

Director, Regulatory Affairs

Lead the development and execution of global regulatory strategies for drug discovery programs, ensuring compliance across jurisdictions including the US, UK, and EU. Collaborate with cross-functional teams to manage regulatory submissions, engage with health authorities, and support clinical development from IND-enabling stages through approval and lifecycle management. Drive regulatory innovation by applying AI-driven platforms to accelerate drug development pathways.

Recursion United Kingdom £111,100 – £141,800 pa

Associate Director, CMC Regulatory Affairs, International

This role involves leading CMC regulatory strategies and submissions for international markets, with a focus on mRNA-based products across vaccines, oncology, and rare diseases. The individual will guide global regulatory compliance, interact with health authorities, and support manufacturing and quality teams through regulatory interpretation and change control. It requires deep expertise in CTD-format filings and a proactive approach to managing multi-therapeutic regulatory programs in a fast-paced environment.

Moderna

On-site Permanent

Head, PV and Regulatory QA

This role leads the global quality and compliance function for pharmacovigilance (PV) systems, ensuring adherence to international regulations and internal standards across clinical safety, regulatory affairs, and medical affairs. The position combines strategic oversight with hands-on operational leadership, including audit strategy, inspection readiness, deviation and CAPA management, and cross-functional GxP guidance. It requires deep technical expertise in PV processes and strong leadership to drive quality across global teams and third-party vendors.

CSL

Head, PV and Regulatory QA

Leads global pharmacovigilance and regulatory quality assurance, ensuring compliance with GVP, ICH, and regulatory standards across clinical safety, medical affairs, and regulatory affairs. Designs audit strategies, manages inspections, and oversees deviation management, CAPA, and change control systems. Provides cross-functional GxP expertise and drives continuous improvement in PV quality systems.

CSL

Associate Director, Regulatory Diagnostics

This role involves designing and delivering global regulatory strategies for precision diagnostics, including companion diagnostics and in vitro devices, within drug development programs. The individual will lead regulatory submissions across the lifecycle, engage with health authorities, and ensure compliance with global regulations. Collaboration with cross-functional teams and external partners is central to advancing regulatory plans for innovative diagnostics in a hybrid working environment.

Novartis London, United Kingdom £67,900 – £126,100 pa

Hybrid Permanent

Manager, Oncology Regulatory Strategy

This role involves leading and implementing regional regulatory strategies for oncology products in the Rest of World (ROW) region, ensuring alignment with global objectives and commercial goals. The individual will represent the region on the Global Regulatory Strategic Team, manage submissions and approvals, and shape interactions with health authorities. A key focus is ensuring compliance while influencing the regulatory environment to accelerate patient access to medicines.

Pfizer Marlow, United Kingdom

Manager, Oncology Regulatory Strategy

Leads regional regulatory strategy for oncology products across the Rest of World (ROW), ensuring alignment with global objectives and timely submissions to health authorities. Works closely with cross-functional teams and external agencies to shape regulatory pathways, influence policy, and secure commercially viable labeling. Focuses on compliance, risk mitigation, and strategic engagement in a dynamic regulatory environment.

Pfizer Sandwich, United Kingdom

Associate Director, Safety Epidemiology – Global Patient Safety

Lead the design and execution of post-authorisation safety studies using real-world data to assess and communicate the safety profiles of AstraZeneca’s medicines. Provide strategic epidemiological input to regulatory submissions, safety signal evaluations, and diversity initiatives, collaborating with internal teams and external partners. Drive methodological excellence in pharmacoepidemiology and contribute to global patient safety decision-making across a broad product portfolio.

AstraZeneca Chatham, ME4 4NP, United Kingdom

On-site Permanent

Global Labelling Director (Team Lead), Content

Leads a team of labelling professionals to develop and maintain global labelling strategies and content for pharmaceutical products. Ensures compliance with regulatory requirements and alignment with product development and lifecycle plans through close collaboration with cross-functional teams and regulatory authorities. Focuses on continuous improvement of labelling processes and high-quality, science-driven documentation.

Novartis London, United Kingdom

Hybrid Permanent