Senior Manager, Regulatory Sciences (m/w/d)

Kurz zusammengefasst

Bristol Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing and delivering innovative medicines that address serious diseases. The Senior Manager, Regulatory Sciences, Innovative Medicines will lead local regulatory oversight for assigned BMS products in Germany, covering the entire lifecycle from clinical development through market launch and post‑approval updates. This role serves as the primary liaison between German health authorities (BfArM, PEI, and other supervisory bodies) and internal teams such as Country Brand, European Regulatory, Medical, and Pharmacovigilance, ensuring that European strategies are clearly communicated and adapted to local requirements. On a day‑to‑day basis the incumbent will translate European regulatory strategies into actionable plans for German cross‑functional teams, flag changes in procedures that could affect health‑technology assessment, and feed market‑specific insights back to European and global regulators. Responsibilities include acting as the contact point for German authorities, contributing to AMNOG dossier preparation and the JCA process, coordinating GMO submissions aligned with clinical trial applications in CTIS, and maintaining compliance for launches and ongoing marketing‑authorisation updates (e.g., SmPCs, PILs). The role also supports the preparation of DHCP letters and risk‑management‑plan materials in close partnership with Pharmacovigilance and Medical departments, and serves as the go‑to expert for in‑ and off‑label queries. The position requires a minimum of four years' experience in regulatory sciences or a related pharmaceutical function, with proven ability to interact directly with health authorities. Candidates must demonstrate fluency in German and a solid grasp of European regulatory requirements, including the AMNOG process and clinical‑trial application procedures. A scientific degree in medicine, pharmacy or natural sciences is essential, as is a comprehensive understanding of the full drug‑development continuum, from pre‑clinical through clinical and pharmaceutical stages. Strong cross‑functional teamwork, and excellent written and spoken communication skills in both English and German, are also mandatory. Preferred attributes include a proactive mindset for communicating regulatory trends, experience supporting clinical‑development strategy, and familiarity with the broader European health‑environment landscape. The role operates under BMS's hybrid work model, offering flexibility while maintaining essential on‑site collaboration. Employees benefit from an inclusive culture that values wellbeing, professional growth, and comprehensive benefits, with dedicated support for people with disabilities and a transparent recruitment process. What the role asks for: - Minimum 4 years regulatory sciences experience in pharma - Fluency in German (professional level) - Proficiency in English (professional level) - Scientific degree in Medical, Pharmaceutical or Natural Sciences - Good knowledge of AMNOG process - Experience supporting clinical development regulatory strategy - Direct interaction experience with health authorities - Understanding of full drug development lifecycle - Knowledge of European clinical trial application requirements - Strong cross‑functional teamwork competency - Excellent verbal and written communication in German and English - Nice‑to‑have: Hybrid work model flexibility