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 Labeling Specialist
Builds
Regulatory submission dossiers and approved product labeling for global markets
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory labeling principles (CCDS, USPI, EU SmPC), Health Authority regulation interpretation, cross-functional team coordination, labeling strategy development, competitive/comparator analysis, project management, conflict resolution, consensus building
Preferred skills
Experience with generics labeling, European Arbitration/referral procedures, PRAC signal detection, statistical knowledge, disease area expertise, public data search for digital capabilities
Technologies
None stated
Responsibilities
Prepare and update corporate labeling documents for company and agency approval; coordinate E2E labeling review and approval including regulatory submissions; chair multi-disciplinary labeling working groups; present labeling proposals to Senior Executive Management; perform labeling competitive analysis; construct company responses to Health Authority questions; support local countries as global labeling SME
Seniority
Mid-Senior, hands-on IC with strategic input
