Director Core Labeling Strategy
Core
Provide regulatory labelling leadership, governance, and expertise to develop, maintain, and implement compliant Product Information texts globally for Viatris products.
Role type
Director, Core Labeling Strategy
Builds
Global Core Data Sheets (CCDS), US Prescribing Information (USPI), EU SmPCs, Target Product Labelling (TPL), and associated patient information.
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
Global labelling strategy, regulatory compliance (US/EU), Target Product Labelling (TPL) development, competitive labelling analysis, cross-functional team leadership, scientific content validation, regulatory submission support (NDA/BLA/MAA), stakeholder management, strategic planning.
Preferred skills
Master's Degree, PharmD, or PhD, experience with innovative product first-cycle labelling, deep knowledge of EU/US regulatory frameworks, industry association engagement.
Technologies
None stated
Responsibilities
Lead global labelling process and development for assigned portfolio; prepare and approve global and territorial labelling documentation; drive labelling strategy in partnership with Global Regulatory; chair cross-functional Product Labeling Teams; manage direct reports and team development; negotiate complex regulatory and scientific issues; represent the company in industry groups and regulatory agency events.
Seniority
Director, strategic leadership with hands-on expertise