Director, Regulatory Strategist
Viatris
August 22, 2026
Remote friendly (Washington, DC)
United States
Corporate Functions
Director, Regulatory Strategist
Responsibilities:
- Develop Global/Regional regulatory strategies and implementation plans for complex projects/products (novel, product enhancements, post-approval), ensuring objectives, standards, delivery time optimization, and successful outcomes.
- Partner with project teams and stakeholders (Clinical, Safety, Medical, GCMC, Quality, R&D, Commercial, Legal) to ensure regulatory deliverables (briefing docs, Regulatory Strategy Documents, annual reports, IND/NDA/MAA, etc.) meet business needs, quality standards, and timelines.
- Provide regulatory input to clinical development, risk/benefit assessments, and target label development.
- Contribute to CCDS development/updates and provide strategic label input as part of the Product Labelling Team.
- Monitor regulatory plans; communicate progress to Senior leadership; clearly communicate and mitigate risks.
- Develop fit-for-purpose submission packages; prepare high-quality documentation to meet requirements/commitments for obtaining/maintaining Marketing Authorizations (including dossier author sections as applicable).
- Align and champion regulatory positions for key issues; execute on time and with required quality standards.
- Build relationships with Health Authority contacts; organize/lead/participate in meetings.
- Support regulatory Due Diligence for business development opportunities.
- Ensure adherence to regulatory processes, systems, working practices, shared learnings, and quality standards.
- Implement regulatory productivity improvements and systems to facilitate information sharing.
- Stay current on global/regional regulations and guidelines; assess impacts and influence environment via Health Authority engagement, Country Office partners, and trade associations.
- Ensure business compliance and adherence to regulatory standards.
Minimum Qualifications:
- B.S. Scientific Degree required; Ph.D./Pharm.D./M.D./M.Sc. or DMS/MBA preferred.
- 8+ years US/EU/EM regulatory experience required; 5+ years Global regulatory experience preferred (consider combination of education/experience).
- Relevant Global and/or Regional regulatory experience.
- Extensive regulatory knowledge; ability to leverage for strategy development/implementation.
- Proven experience managing global/regional regulatory and registration activities across drug development and/or post-marketing lifecycle; manage complex issues; multiple products/simultaneous lifecycle stages desirable.
- Track record delivering to time/cost/quality; strong matrixed organization delivery.
- Proven partnership skills with Regulatory, Commercial, Safety, Medical, and other stakeholders.
- Proven success negotiating with major Health Authorities, including leading interactions.
- Strategic thinking and ability to translate into actionable plans.
- Strong written and verbal communication.
- Regulatory Affairs Professional Certification preferred.
- English proficiency required.
Preferred/Desirable:
- Strong breadth/depth of regulatory strategy enabling leadership with minimal supervision.
Benefits/Compensation:
- Salary range: $112,000.00–$236,000.00 USD (exact compensation varies).
Work/Logistics:
- Hybrid: DC office 2 days per week; periodic travel may be required.
Application instructions:
- Not provided in the text.
Responsibilities:
- Develop Global/Regional regulatory strategies and implementation plans for complex projects/products (novel, product enhancements, post-approval), ensuring objectives, standards, delivery time optimization, and successful outcomes.
- Partner with project teams and stakeholders (Clinical, Safety, Medical, GCMC, Quality, R&D, Commercial, Legal) to ensure regulatory deliverables (briefing docs, Regulatory Strategy Documents, annual reports, IND/NDA/MAA, etc.) meet business needs, quality standards, and timelines.
- Provide regulatory input to clinical development, risk/benefit assessments, and target label development.
- Contribute to CCDS development/updates and provide strategic label input as part of the Product Labelling Team.
- Monitor regulatory plans; communicate progress to Senior leadership; clearly communicate and mitigate risks.
- Develop fit-for-purpose submission packages; prepare high-quality documentation to meet requirements/commitments for obtaining/maintaining Marketing Authorizations (including dossier author sections as applicable).
- Align and champion regulatory positions for key issues; execute on time and with required quality standards.
- Build relationships with Health Authority contacts; organize/lead/participate in meetings.
- Support regulatory Due Diligence for business development opportunities.
- Ensure adherence to regulatory processes, systems, working practices, shared learnings, and quality standards.
- Implement regulatory productivity improvements and systems to facilitate information sharing.
- Stay current on global/regional regulations and guidelines; assess impacts and influence environment via Health Authority engagement, Country Office partners, and trade associations.
- Ensure business compliance and adherence to regulatory standards.
Minimum Qualifications:
- B.S. Scientific Degree required; Ph.D./Pharm.D./M.D./M.Sc. or DMS/MBA preferred.
- 8+ years US/EU/EM regulatory experience required; 5+ years Global regulatory experience preferred (consider combination of education/experience).
- Relevant Global and/or Regional regulatory experience.
- Extensive regulatory knowledge; ability to leverage for strategy development/implementation.
- Proven experience managing global/regional regulatory and registration activities across drug development and/or post-marketing lifecycle; manage complex issues; multiple products/simultaneous lifecycle stages desirable.
- Track record delivering to time/cost/quality; strong matrixed organization delivery.
- Proven partnership skills with Regulatory, Commercial, Safety, Medical, and other stakeholders.
- Proven success negotiating with major Health Authorities, including leading interactions.
- Strategic thinking and ability to translate into actionable plans.
- Strong written and verbal communication.
- Regulatory Affairs Professional Certification preferred.
- English proficiency required.
Preferred/Desirable:
- Strong breadth/depth of regulatory strategy enabling leadership with minimal supervision.
Benefits/Compensation:
- Salary range: $112,000.00–$236,000.00 USD (exact compensation varies).
Work/Logistics:
- Hybrid: DC office 2 days per week; periodic travel may be required.
Application instructions:
- Not provided in the text.