Latest regulatory affairs Jobs

GSK logo

Director - Diagnostic Execution (Oncology Translational Medicine)

This role involves leading the operational delivery of biomarker and diagnostic strategies for GSK's oncology portfolio, particularly focusing on Antibody Drug Conjugate (ADC) development. Responsibilities include managing a team, overseeing external testing partners, and ensuring regulatory compliance and successful drug-diagnostic co-development.

GSK
GSK logo

Senior Medical Director, Oncology Clinical Development - GU

Lead clinical development for oncology assets, focusing on genitourinary (GU) cancers, with responsibility for designing and executing global Phase 1-3 trials. Drive medical strategy, collaborate with key external experts, and ensure scientific integrity across clinical programs. Work within a matrix environment to support regulatory filings and lifecycle management of innovative therapies.

GSK £284,250 – £473,750 pa
Hybrid Permanent

Senior Manager, Government Affairs – UK

This role involves shaping and executing Moderna’s Government Affairs strategy across the UK, with a focus on enabling innovative mRNA-based respiratory vaccines through policy engagement. The individual will build relationships with government, Parliament, and healthcare stakeholders, translate political and policy trends into strategic positions, and leverage AI tools to enhance policy intelligence. Collaboration across internal teams and external partners is key to influencing public policy and supporting Moderna’s mission in a fast-paced, innovation-driven environment.

Moderna London, United Kingdom

Data Business Translation and Reporting Manager

This role involves translating business questions into actionable analytics and reporting solutions, partnering with Commercial, Medical Affairs, and Value & Access teams to ensure insights drive strategic decisions. Responsibilities include documenting business requirements, maintaining reporting cadences, and continuously improving analytics products.

Novartis London, United Kingdom £47,740 – £88,660 pa

Global Regulatory Associate Director, Life Cycle Management

Manages regulatory maintenance for a high-complexity pharmaceutical portfolio, ensuring compliance and timely submissions. Develops strategic regulatory input for safety reports, variations, and renewals, while acting as a liaison with health authorities. Supports global approval processes and contributes to process improvements and team mentorship.

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

Associate Director, Global Regulatory Science, CMC

Leads global regulatory strategy for CMC (Chemistry, Manufacturing, and Controls) in support of mRNA-based medicines, ensuring compliance with international regulations and guiding submissions across multiple therapeutic areas. Works closely with manufacturing, quality, and development teams to prepare high-quality regulatory documentation and engage with health authorities. Focuses on biologics, particularly in vaccines, oncology, and rare diseases, within a rapidly expanding biotech environment.

Moderna London, United Kingdom
Hybrid Permanent
CSL logo

Global Safety Lead - Formulation Safety

Leads global safety strategy for formulation safety within CSL's GSPV department, overseeing clinical safety evaluation across product lifecycles. Responsible for signal detection, risk management planning, and regulatory compliance across clinical development and post-marketing phases. Serves as safety representative in cross-functional teams, ensuring alignment with medical, regulatory, and business objectives.

CSL
CSL logo

Associate Director, Biostatistics

This role leads the statistical strategy for clinical development programs, overseeing study design, data analysis, and regulatory submissions. The individual will guide biostatistical input across trials, interact with regulatory authorities, and ensure accurate reporting of results. Collaboration with cross-functional teams and oversight of internal or outsourced programming efforts are key aspects of the position.

CSL
Hybrid Permanent

Information Security Manager

The Information Security Manager will lead information security, product cybersecurity, and cyber risk management in a growing, highly regulated digital health technology environment. Key responsibilities include maintaining the ISMS, conducting risk assessments, overseeing penetration testing, and embedding cybersecurity in software development processes.

Reed Technology Cambridge, Cambridgeshire, United Kingdom £85,000 – £100,000 pa

VP, Clinical Operations and Data Management

Leads the end-to-end delivery of global clinical trials from start-up to close-out, ensuring compliance, data integrity, and on-time execution. Oversees clinical operations and data management functions, including vendor and site management, database design, and regulatory coordination. Focuses on strategic planning, cross-functional collaboration, and team development within a regulatory-compliant environment.

Orchard Therapeutics London, United Kingdom
Hybrid

Head of Production

The Head of Production will lead the initial validation and regulatory approval process for a new pharmaceutical manufacturing site, working with Home Office and MHRA. Responsibilities include authoring SOPs, audit readiness, and building a compliant production team.

SRG Galashiels, Alba / Scotland, United Kingdom

Records Management Associate

This role involves managing the security, storage, and retrieval of proprietary and client information, using scanning equipment and maintaining accurate records. The position also includes developing and implementing a sustainability strategy for IQVIA Laboratories and providing reference services to internal clients.

IQVIA Livingston, Alba / Scotland, EH54 6GS, United Kingdom
On-site Permanent
Isomorphic Labs logo

Senior Scientist (In vivo Pharmacology & Translational Sciences), Cambridge, MA

Lead translational strategies for oncology and immunology programs by designing in vivo pharmacology and PK/PD studies to validate AI-designed drug candidates. Bridge computational predictions with experimental validation through CRO partnerships and biomarker-driven approaches. Drive preclinical data generation to inform clinical trial design and regulatory filings.

Isomorphic Labs England
Hybrid Permanent
Isomorphic Labs logo

Research Leader (DMPK), Cambridge, MA

Lead DMPK strategy for drug discovery projects using an AI-first approach, integrating quantitative pharmacology and ADME data to guide candidate selection. Collaborate with chemistry, pharmacology, and machine learning teams to optimise molecule design and advance predictive models. Contribute to regulatory documentation and drive innovation in human PK prediction and biotransformation understanding.

Isomorphic Labs Cambridge, United Kingdom
Recursion logo

Executive Director, Asset Team Lead

The Executive Director, Asset Team Lead, will drive the strategic positioning of clinical assets in oncology and immunology, leveraging Recursion's proprietary OS and ClinTech insights. This role involves cross-functional collaboration to ensure the advancement of transformative medicines, with a focus on competitive positioning and patient benefit.

Recursion United Kingdom