Senior GRA Labeling Specialist
Core
Lead global labeling strategy, prepare and update corporate labeling documents (CCDS, USPI, EU SmPC), and coordinate regulatory submissions and negotiations for marketed pharmaceutical products.
Role type
Senior Global Regulatory Affairs Labeling Specialist
Builds
Corporate labeling documents and regulatory submission dossiers for marketed and life-cycle products
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Global labeling strategy, regulatory document preparation (CCDS, USPI, EU SmPC), cross-functional team leadership, regulatory negotiation, pharmacovigilance data assessment, competitive analysis, project management
Preferred skills
Experience with generics/authorized generics/private labels, therapeutic area scientific knowledge, digital data search capabilities
Technologies
CCDS, USPI, EU SmPC, Health Authority submission systems
Responsibilities
Lead labeling strategy and prepare/update corporate labeling documents, coordinate E2E labeling review and approval process, chair multi-disciplinary labeling working groups, negotiate with health authorities, assess study reports and pharmacovigilance data, perform competitive/comparator analysis
Seniority
Senior, hands-on IC with strategic oversight