Team Lead GRA Labeling Strategist Transversal
Core
Define and lead global labeling strategy for new and existing pharmaceutical products to obtain Marketing Authorizations and ensure compliance across US, EU, and WHO markets.
Role type
Senior Team Lead, Regulatory Affairs (Labeling Strategy)
Builds
Corporate labeling documents (CCDS, US, EU, WHO), patient leaflets, and submission dossiers for regulatory agencies.
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Required skills
Global regulatory strategy, labeling requirements (US/EU/WHO), cross-functional team leadership, negotiation, consensus building, project management, training/mentoring, scientific data interpretation, document management systems.
Preferred skills
People management experience, advanced degree in Life Sciences, familiarity with therapeutic areas.
Technologies
Veeva Vault, EDMS, RIM systems, text verification/QC tools.
Responsibilities
Define and lead labeling strategy for development and marketed products; coordinate E2E labeling review and approval; chair multi-disciplinary labeling working groups; provide strategic guidance and oversight for assigned products; support Response Teams for complex regulatory issues; assess study reports and pharmacovigilance data; perform competitive labeling analysis; train and mentor team members.
Seniority
Senior, hands-on IC with people management responsibilities