Director Core Labeling Strategy
Viatris
August 21, 2026
Remote friendly (Washington, DC)
United States
Corporate Functions
Director Core Labeling Strategy
Responsibilities:
- Provide regulatory labelling leadership, governance, and expertise to ensure global compliance of product information (labelling) for existing and new products.
- Create, develop, and maintain compliant core labelling documents (e.g., CCDS) and associated patient information; oversee Global Ad Promo and Medical Marketing review/approval.
- Lead global labelling process for assigned portfolio; prepare, review, and approve global and territorial labelling documents (e.g., CCDS, Core Patient Information, EU SmPCs, US Prescribing Information) to support international filings.
- Drive labelling strategy with Global Regulatory, including competitive labelling analysis and impact assessment for CCDS, USPI (ANDA/NDA/BLA), and group-managed EU SmPCs.
- Lead development/maintenance of Target Product Labelling (TPL); support early development and major submissions (incl. USPI).
- Manage compliance by reconciling deviations with core positioning; assess change requests, respond to health authorities, and approve outcomes.
- Chair cross-functional Product Labeling Teams; ensure PI content is scientifically accurate, validated, and aligned with safety/clinical requirements; escalate disputes to Global Labelling Committee.
- Negotiate resolution of complex regulatory/scientific issues; manage multiple projects; review/approve promotional materials and relevant scientific documents (e.g., protocols/reports, PSURs, RMP, ACO, Core Value Dossiers).
- Supervise direct reports and contribute to Global Labelling Organization leadership; represent labelling externally as needed.
Minimum Qualifications:
- Bachelor’s degree (Science/Medicine/Pharmacy or related) + 10 years regulatory experience, including global labelling strategy/development. Preferred: Master’s/PharmD/PhD.
- Demonstrated experience developing/maintaining global core labelling (CCDS) and major market labelling (USPI, EU SmPCs).
- Strong preference: first-cycle/initial submission labelling for innovative products (NDA/BLA, MAA).
- Advantage: TPL development, competitive benchmarking, regulatory submission support.
- Deep global labelling knowledge (development + lifecycle), governance understanding (PLT/GLC), and EU/US labelling requirements.
- Leadership experience managing direct reports.
- Ability to interpret complex research, write scientific/technical correspondence, communicate with executives, and present externally.
- Strong interpersonal, presentation, and communication skills; effective in matrixed environments.
Compensation:
- Salary range: $112,000–$236,000.
Responsibilities:
- Provide regulatory labelling leadership, governance, and expertise to ensure global compliance of product information (labelling) for existing and new products.
- Create, develop, and maintain compliant core labelling documents (e.g., CCDS) and associated patient information; oversee Global Ad Promo and Medical Marketing review/approval.
- Lead global labelling process for assigned portfolio; prepare, review, and approve global and territorial labelling documents (e.g., CCDS, Core Patient Information, EU SmPCs, US Prescribing Information) to support international filings.
- Drive labelling strategy with Global Regulatory, including competitive labelling analysis and impact assessment for CCDS, USPI (ANDA/NDA/BLA), and group-managed EU SmPCs.
- Lead development/maintenance of Target Product Labelling (TPL); support early development and major submissions (incl. USPI).
- Manage compliance by reconciling deviations with core positioning; assess change requests, respond to health authorities, and approve outcomes.
- Chair cross-functional Product Labeling Teams; ensure PI content is scientifically accurate, validated, and aligned with safety/clinical requirements; escalate disputes to Global Labelling Committee.
- Negotiate resolution of complex regulatory/scientific issues; manage multiple projects; review/approve promotional materials and relevant scientific documents (e.g., protocols/reports, PSURs, RMP, ACO, Core Value Dossiers).
- Supervise direct reports and contribute to Global Labelling Organization leadership; represent labelling externally as needed.
Minimum Qualifications:
- Bachelor’s degree (Science/Medicine/Pharmacy or related) + 10 years regulatory experience, including global labelling strategy/development. Preferred: Master’s/PharmD/PhD.
- Demonstrated experience developing/maintaining global core labelling (CCDS) and major market labelling (USPI, EU SmPCs).
- Strong preference: first-cycle/initial submission labelling for innovative products (NDA/BLA, MAA).
- Advantage: TPL development, competitive benchmarking, regulatory submission support.
- Deep global labelling knowledge (development + lifecycle), governance understanding (PLT/GLC), and EU/US labelling requirements.
- Leadership experience managing direct reports.
- Ability to interpret complex research, write scientific/technical correspondence, communicate with executives, and present externally.
- Strong interpersonal, presentation, and communication skills; effective in matrixed environments.
Compensation:
- Salary range: $112,000–$236,000.