Senior Regulatory Affairs Consultant

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hw6s0

Experteer Overview In this role you will be the principal labeling strategist within Global Regulatory Affairs, driving labeling strategy and the creation and upkeep of CCDS, dCCDS, USPI, and EU SmPC for the product portfolio. You will align labeling with regulatory, registration, and development plans while supporting early development and cross-functional teams. You'll lead global labeling discussions, ensure consistency across CCDS and product labels, and represent Global Labeling in strategy forums. This position offers a hybrid setup and the chance to influence labeling standards at a global scale.
Retribuzione / Benefits Generate and maintain dCCDS, CCDS, USPI, and EU SmPC as assigned
Deliver labeling strategy for early development to inform claims
Contribute labeling perspective to Clinical Study designs, Protocols, and Briefing Books
Lead interactions with SMEs (GCSP, GCD, GRA, CDO) for dCCDS/CCDS labeling
Collaborate on USPI and EU SmPC reviews with regional leads
Communicate updates to Global Labeling Operation Managers and regions




Lead assessment of exceptions between CCDS and USPI/SmPC via Global Labeling Committee processes
Escalate compliance issues to Director, Global Labeling Strategy
Represent Global Labeling in GRA Strategy Teams and TA teams
Stay up to date with global labeling requirements
Represent Global Labeling in internal and external meetings
Build cross-functional networks within GRA, R&D;, and Commercial Development
Responsabilità University degree in Life Sciences or related Pharmaceutical field
Minimum of 10 years in biotech/pharmaceutical industry with at least 6 years in labeling/regulatory experience
Knowledge of regulatory principles related to drug development, global labeling, and post-marketing requirements
Strong scientific background with ability to translate scientific content into labeling
Proven problem‐solving ability and risk assessment skills
Proficient regulatory and drug/biologic development knowledge from pre‐clinical t

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hw6s0