Senior Global Regulatory Affairs Leader (a)

- Lead EU and global regulatory strategy for innovative programmes - High-impact role with broad cross-functional visibility

Our client is a leading international pharmaceutical organisation with a strong global presence and a commitment to improving patient access to healthcare solutions. Due to ongoing business needs and portfolio growth, they are looking for an experienced regulatory leader who can join the team with a quick start. Hybrid work model. Job Description - Define and execute EU and global regulatory strategies aligned with development objectives - Act as the primary regulatory contact for European health authorities and coordinate regulatory interactions - Lead regulatory agency meetings, scientific advice procedures, and preparation of briefing documentation - Oversee preparation and submission of regulatory dossiers throughout the product lifecycle - Drive global submission planning, execution, and regulatory milestone delivery - Ensure compliance of product information and labelling activities across markets - Represent Regulatory Affairs within cross-functional project teams and governance forums - Monitor evolving regulatory requirements and assess business impact - Provide regulatory expertise for business development, partnerships, and due diligence activities - Lead regulatory sub-teams and support affiliates and external partners on strategic regulatory matters The Successful Applicant - Master's degree in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline - Minimum 8 years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry - Strong expertise in EU regulatory procedures and global regulatory frameworks - Proven experience interacting with EMA and European health authorities - Deep understanding of clinical development, registration pathways, and lifecycle management - Demonstrated leadership skills within complex international projects - Excellent stakeholder management, communication, and influencing abilities - Fluent English, both written and spoken - Ability to work effectively in cross-functional and global matrix environments What's on Offer - Strategic regulatory leadership position - International and highly visible role - Broad exposure to EU and global regulatory activities - Hybrid work model (3 days onsite, 2 days HO)