Latest regulatory affairs Jobs

Spotlight

Senior Clinical Trial Case Manager

This role involves leading safety data review and pharmacovigilance activities within clinical trials, ensuring compliance with international regulations such as GxP. The individual will mentor team members, manage CAPAs, support regulatory inspections, and contribute to safety reporting and risk management. Key responsibilities include MedDRA coding, safety data analysis, and developing pharmacovigilance procedures to support global regulatory requirements.

CSL

On-site Permanent

Spotlight

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

Regulatory Affairs Manager

The Regulatory Affairs Manager will lead day-to-day regulatory activities, maintaining and developing technical documentation for existing and future medical devices and IVD products. You'll support UKCA and CE marking, regulatory strategies, and collaborate with scientific, data, and technical teams to ensure compliance throughout product development.

Cure Talent Hildersham, Cambridgeshire, United Kingdom £60,000 – £75,000 pa

Senior Regulatory Affairs Specialist UK and Ireland

This role involves leading regulatory strategy and hands-on activities for medicinal products, medical devices, and cosmetics in the UK and Ireland. Responsibilities include managing regulatory submissions, ensuring compliance, and supporting product launches and lifecycle management.

GI Group Tottenham Court Road, London, United Kingdom

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

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

Undergraduate Regulatory Strategist

This role involves working in Pfizer's Regulatory Strategy department, contributing to the development and implementation of regulatory strategies for innovative medicinal products. Responsibilities include compiling regulatory documents, engaging with health authorities, and maintaining systems and processes. The position offers a unique overview of the pharmaceutical product life cycle from research to market.

Pfizer United Kingdom

Head of Quality - Pharmaceuticals

This role involves leading all quality and regulatory functions in a growing pharmaceutical company, ensuring GMP compliance, patient safety, and continuous improvement. Responsibilities include managing quality systems, regulatory inspections, and supplier audits, as well as driving a culture of quality and compliance.

Reed Specialist Recruitment St Albans, Hertfordshire, United Kingdom

On-site Permanent

Senior Medical Director, Oncology Clinical Development - GU

This role involves leading clinical development activities for GSK’s oncology portfolio, with a focus on genitourinary (GU) cancers. The Senior Medical Director will design and execute Phase 1-3 clinical trials, provide medical oversight, interpret clinical data, and engage with external experts and regulatory authorities. The position requires strong leadership in a matrixed environment and deep expertise in oncology drug development.

GSK Stevenage, United Kingdom US$284,250 – US$473,750 pa

Hybrid Permanent

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 Stevenage, United Kingdom

Executive Director, Clinical Pharmacology/Pharmacometrics

This role involves leading clinical pharmacology and pharmacometrics strategies for rare disease and oncology programs, designing clinical studies, and interfacing with regulatory authorities. The position requires extensive experience in drug development, proficiency with modeling software, and collaboration with cross-functional teams.

Recursion United Kingdom

Regional Head, Pharmacovigilance Quality (PVQA)

This role involves providing end-to-end quality assurance and vigilance expertise for global and local pharmacovigilance activities. Responsibilities include driving regional quality oversight, ensuring compliance with regulations, and leading quality improvement initiatives.

Novartis London, United Kingdom £63,917 – £118,703 pa

Director of Nonclinical Safety, Cambridge, MA

Lead the development and execution of nonclinical safety strategies for small molecule drug candidates in oncology and non-oncology programs, integrating AI-driven predictive models with traditional toxicology. Build and scale the nonclinical safety function within an AI-first drug discovery environment, ensuring high-quality data feedback to refine computational models. Collaborate across preclinical, clinical, and regulatory teams to advance compounds through IND and NDA/MAA-enabling studies.

Isomorphic Labs Cambridge, United Kingdom

Associate Director / Director, Biostatistics

This role involves providing strategic statistical leadership for Health Technology Assessment, pricing, and reimbursement activities. The candidate will work with cross-functional teams to ensure HTA evidence is scientifically rigorous and aligned with payer requirements. Responsibilities include implementing HTA methods, contributing to evidence synthesis, and mentoring biostatisticians.

Novartis London, United Kingdom

Executive Director / Vice President, Business Development

Lead business development strategy to identify and execute strategic partnerships, in- and out-licensing deals, co-developments, and M&A opportunities in oncology and autoimmune disease. Represent Autolus at high-level meetings, build relationships across biotech, pharma, and academia, and collaborate with cross-functional teams to align BD initiatives with corporate goals. Requires deep expertise in biopharma deal-making and strong scientific-business acumen.

Autolus

Compliance Engineer

The Compliance Engineer will be responsible for creating, reviewing, and maintaining regulatory and technical documentation to ensure products remain compliant and audit-ready. Key responsibilities include authoring technical files, supporting EU MDR and UK regulatory compliance, and assisting with Notified Body and external audit requirements.

Aurora Life Sciences Doncaster, South Yorkshire, United Kingdom £50,000 pa

Associate Director, Biostatistics

The Associate Director, Biostatistics, leads statistical contributions to clinical development programs, including study design, data analysis, and regulatory submissions. They collaborate with cross-functional teams, manage outsourcing, and ensure the quality and timeliness of deliverables.

CSL £212,000 – £251,000 pa

Hybrid Permanent