Regulatory Affairs Manager

The Regulatory Affairs Manager at Amgen Breda will provide expertise in translating CMC regulatory requirements into actionable plans, supporting the preparation of regulatory submissions and post‑market supplements, and serving as the key RA‑CMC liaison for change control, deviations, and communications with business partners and authorities. The role involves leading site‑specific regulatory strategies, collaborating with cross‑functional teams, and ensuring compliance with GMP and regulatory standards.