Senior Manager, Core Labeling Strategy
Core
Lead global regulatory labelling strategy and ensure Product Information compliance for existing and new healthcare products.
Role type
Senior Manager, Core Labeling Strategy
Builds
Global core labelling (CCDS), patient information, and territorial labelling (USPI, EU SmPC) for pharmaceutical products.
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
Global regulatory labelling expertise, Target Product Labelling (TPL) development, competitive labelling analysis, cross-functional leadership, strategic planning, risk management, scientific accuracy evaluation, health authority response management.
Preferred skills
Regulatory submission support (NDA/BLA/MAA), advanced degree in Science/Medicine/Pharmacy, experience in TPL development, competitive benchmarking.
Technologies
CCDS, USPI, EU SmPC, IB, protocols, CSR, PSURs, RMPs
Responsibilities
Develop and maintain global core labelling and patient information; lead labelling strategy in partnership with Global Regulatory; chair Product Labelling Teams (PLTs); manage complex regulatory and scientific labelling issues; review and approve promotional and non-promotional materials; represent company in external regulatory forums.
Seniority
Senior Manager, hands-on leadership with supervisory responsibilities