Team Lead GRA Labelling Strategist
Core
Define and lead labeling strategy to create or update corporate labeling documents (CCDS, US, EU, WHO) and patient leaflets for development and marketed pharmaceutical products to obtain Marketing Authorizations.
Role type
Senior Team Lead, Regulatory Affairs Labeling Strategist
Builds
Corporate labeling documents, patient leaflets, and submission dossiers for regulatory agencies (US, EU, WHO)
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Required skills
Regulatory strategy, labeling document creation, cross-functional team leadership, matrix team management, regulatory negotiation, performance management, resource planning, training and mentoring, project management, scientific data interpretation
Preferred skills
Advanced degree in Life Sciences, experience with drug-device combinations, familiarity with document management systems (Veeva Vault, EDMS)
Technologies
Veeva Vault, EDMS, RIM systems, text verification/QC tools
Responsibilities
Define and lead labeling strategy for new indications and product updates; coordinate end-to-end labeling review and approval processes; chair multi-disciplinary labeling working groups; provide strategic guidance and training to the team; manage resource planning and product responsibility allocation; construct Company Responses to Health Authority questions; assess study reports and pharmacovigilance data; lead process improvement workstreams.
Seniority
Senior, hands-on IC with people management responsibilities