Senior Manager, Regulatory Sciences (m/w/d)
Core
Local regulatory oversight for BMS products in Germany from clinical development through marketed lifecycle, ensuring compliance with Marketing Authorisations and national requirements.
Role type
Senior Manager, Regulatory Sciences (Germany)
Builds
Supports pipeline strategy, AMNOG dossiers, and JCA processes for German market launches.
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
German regulatory requirements, AMNOG process, Health Authority interaction, drug development lifecycle, clinical trial applications, SmPC/PIL updates, Pharmacovigilance collaboration
Preferred skills
European regulatory strategies, cross-functional teamwork, scientific background
Technologies
CTIS, SmPC, PIL, RMP, DHCP letters
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; GMO submission alignment with clinical trials; Ensure compliant implementation of launches and Marketing Authorisation updates; Prepare DHCP letters and RMP materials.
Seniority
Senior Manager, hands-on IC