Senior Manager, Regulatory Sciences (m/w/d)
Core
Local regulatory oversight of BMS products in Germany from clinical development through marketed lifecycle, ensuring compliance with Marketing Authorisations and national requirements.
Role type
Senior Manager, Regulatory Sciences (Innovative Medicines)
Builds
Regulatory strategies, AMNOG dossiers, and compliant launch materials for German market
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
German regulatory requirements, AMNOG process, clinical development lifecycle, health authority interaction, marketing authorisation compliance, pivotal study knowledge
Preferred skills
European regulatory strategies, clinical trial applications, pharmacovigilance collaboration, scientific background
Technologies
CTIS, SmPC, PIL, RMP, DHCP
Responsibilities
Proactive communication of European regulatory strategies to local teams; Contact person for German health authorities (BfArM/PEI); Active member of AMNOG dossier and Country Brand Teams; Ensure compliant implementation of launches and updates to Marketing Authorisations; Coordinate GMO submissions aligned with clinical trials
Seniority
Senior Manager, hands-on leadership