GRA Labelling Specialist
Core
Prepare and coordinate regulatory labeling documents (CCDS, USPI, EU SmPC) for marketed pharmaceutical products, ensuring compliance with health authority regulations and supporting global regulatory strategy.
Role type
Senior Regulatory Affairs Specialist (Labeling)
Builds
Regulatory labeling dossiers and approved product information for global markets
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory labeling expertise (CCDS, USPI, EU SmPC), cross-functional team leadership, regulatory strategy integration, health authority negotiation, project management, analytical thinking
Preferred skills
Experience with generics labeling, knowledge of European Arbitration/referrals procedures, signal detection in pharmacovigilance, public data search capabilities
Technologies
None stated
Responsibilities
Prepare and update corporate labeling documents for company and agency approval; coordinate E2E labeling review and approval processes; lead multidisciplinary labeling working groups; present labeling proposals to Senior Executive Management; perform competitive/comparator analysis; construct company responses to health authority questions; support local countries as global labeling SME.
Seniority
Mid-Senior, hands-on IC with oversight on complex topics