Head of Regulatory Affairs

A leading global biopharmaceutical organisation are seeking a

Head of Regulatory Affairs

to lead global and regional regulatory strategy across development, licensure, and post-approval lifecycle management. This role will collaborate closely with R&D, Clinical, Quality, Manufacturing, and Commercial functions to drive product success across multiple markets. Key Responsibilities Provide strategic leadership across all Regulatory Affairs functions, including CMC, Development, Post-Authorisation, EU & International Markets, North America, Partner Markets, Regulatory Operations, and Labelling. Develop and execute global regulatory strategies from preclinical through post-marketing stages. Advise senior leadership on regulatory pathways, opportunities, and risks. Represent the organisation in interactions with major health authorities (e.g., FDA, EMA, MHRA, WHO). Oversee the preparation and timely submission of high-quality regulatory filings (INDs, BLAs/MAAs, amendments, and variations). Monitor regulatory intelligence and assess potential business or process impacts. Embed regulatory considerations into development programs, including clinical plans, manufacturing, tech transfers, scale-up, and labelling. Build, develop, and mentor a high-performing Regulatory Affairs team, delivering across multiple priority programs in parallel. Lead post-approval regulatory activities and ensure ongoing global compliance. Qualifications Advanced degree in a scientific, medical, or regulatory discipline (PhD, PharmD, MD, or MSc preferred). 15+ years’ experience in Regulatory Affairs within biotech, pharma, or vaccines, including 5+ years in senior leadership. Experience across vaccines and/or biologics strongly preferred. Demonstrated success leading major regulatory submissions and approvals. Strong knowledge of U.S. and EU regulatory frameworks; additional global market experience is an advantage. Excellent leadership, communication, and stakeholder-management capability. Proven ability to balance innovation, compliance, and risk in a complex, cross-functional environment.