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
Builds
Ensures compliant implementation of launches and updates to Marketing Authorisations (SmPCs/PILs, regulatory documents)
Domain
Pharmaceuticals, Regulatory Affairs, Germany
Required skills
German regulatory requirements and procedures, AMNOG process, clinical development strategy, direct interaction with Health Authorities, drug development lifecycle, European clinical trial applications, industry and external health environment
Preferred skills
Scientific background (Medical/Pharmaceutical/Natural Sciences), cross-functional teamwork, communication in English and German
Technologies
CTIS, SmPC, PIL, RMP, DHCP letters
Responsibilities
Proactive communication of European regulatory strategies to Country Cross Functional Teams, contact person for German regulatory authorities (BfArM/PEI), active member of AMNOG dossier team and JCA process, GMO submission aligned with clinical trial applications, ensure compliant implementation of launches and updates to Marketing Authorisations, close cooperation with Pharmacovigilance and Medical Department
Seniority
Senior Manager, hands-on IC