Labeling strategist - Reg Affairs AD
Core
Lead global labeling strategy and author key regulatory documents (TPL, PI, IFU) for new and registered pharmaceutical assets, guiding product development from preclinical stages through registration.
Role type
Senior IC regulatory affairs strategist (labeling)
Builds
Target Product Labels, Company Core Data Sheets, Prescribing Information, and Patient Information for global regulatory submissions
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Global labeling strategy, Target Product Label (TPL) authoring, eCTD dossier management, regulatory intelligence analysis, cross-functional team leadership, budget forecasting, contract management, proposal development, team mentorship
Preferred skills
Experience with biologics, medical devices, or combined products, clinical development background, knowledge of Safety Management Team (SMT) processes, PV inspector/auditor interview preparation
Technologies
Veeva Vault, Adobe Acrobat Pro, Microsoft Office Suite, Regulatory Information Management Systems, Electronic Document Management Systems
