Manager, Core Labeling Strategy
Core
Develop, maintain, and implement global regulatory labeling (Product Information, CCDS, USPI, EU SmPC) for existing and new pharmaceutical products to ensure compliance with regulatory requirements.
Role type
Manager, Core Labeling Strategy
Builds
Global core labeling documentation, Target Product Labelling (TPL), and regulatory submissions supporting product lifecycle strategy.
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (regulatory documentation)
Required skills
Global regulatory labeling expertise, development of Core Labelling (CCDS), major market labeling (USPI, EU SmPC), regulatory submission support, Target Product Labelling (TPL) development, competitive labeling analysis, cross-functional partnership management, scientific accuracy evaluation, deviation assessment, Health Authority response support, emerging regulatory guideline interpretation.
Preferred skills
NDA/BLA/MAA submission support, TPL development, competitive labeling benchmarking, regulatory strategy support.
Technologies
CCDS, USPI, EU SmPC, TPL, IB, protocols, CSR, PSURs, RMPs
Responsibilities
Develop and maintain global core labeling and territorial labeling; support regulatory submissions; lead labelling updates and development; chair Product Labelling Teams; assess deviations from Company Core Position; review and approve promotional and non-promotional materials; provide expertise in cross-functional discussions.
Seniority
Manager, hands-on IC with strategic oversight
