Mgr Global Regulatory Scientist, Reg Aff

Role: Manager Global Regulatory Scientist in Regulatory Affairs, focusing on preparing and supporting submissions for innovative medicines across global health authorities. Responsibilities: draft cover letters, manage IND, CTA, NDA, MAA, and eCTD applications; ensure regulatory compliance in protocols; advise on submission strategies; coordinate meetings with agencies; track critical submission timelines; provide regulatory input on inspections and audits; participate in global teams and develop regulatory strategies. Requirements: Bachelor's degree in a scientific discipline (advanced degree preferred); 4+ years of regulatory affairs experience in pharma/biotech; knowledge of FDA, ICH regulations, and global regulatory processes; experience with clinical trial lifecycle, product registration, and health authority interactions; familiarity with oncology or combination products is beneficial. HighValue: global regulatory submissions, clinical development, life cycle management, oncology experience, multi-product expertise (pharma, device, combo). WorkSetup: hybrid position based in Belgium, Netherlands, UK, or US; travel approximately 10% domestically and potentially internationally.