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 enhancement, post-approval), optimizing delivery time and success probability.
- Partner with project teams/stakeholders (Clinical, Safety, Medical, GCMC, Quality, R&D, Commercial, Legal) to ensure regulatory contributions (briefing docs, Regulatory Strategy Documents, annual reports, IND/NDA/MAA, etc.) meet quality standards and timelines.
- Provide regulatory input to clinical development programs, risk/benefit assessments, and target label development.
- Support Product Labelling Team: contribute to CCDS development/updates and strategic label input/maintenance.
- Monitor regulatory plans; communicate progress and emerging risks to Senior leadership and mitigate where possible.
- Develop fit-for-purpose submission packages and ensure dossier documentation meets requirements/commitments for Marketing Authorizations.
- Align and champion regulatory positions for key issues; ensure timely, high-quality execution.
- Maintain relationships with Health Authority contacts; lead/participate in agency meetings as appropriate.
- Support regulatory due diligence for business development.
- Ensure adherence to regulatory team processes/systems/working practices/quality standards.
- Implement processes to improve regulatory productivity and enable information sharing across lines.
- Track evolving regulations/guidelines and assess impacts; influence through Health Authority engagement, Country Office partners, and trade associations.
- Ensure business compliance with regulatory standards.
Minimum Qualifications:
- B.S. Scientific Degree required; advanced degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or DMS/MBA preferred.
- 8+ years US/EU/EM Regulatory experience required; 5+ years Global Regulatory experience preferred (education/experience combination considered).
- Relevant Global/Regional regulatory experience; strong knowledge of regulatory environment.
- Proven experience managing global/regional regulatory & registration and/or post-marketing lifecycle; manage complex issues; desirable: multiple products across lifecycle stages.
- Proven time/cost/quality delivery; strong matrix teamwork; strategic thinking.
- Track record negotiating with major Health Authorities, including leading interactions.
- Strong written/verbal communication.
- Regulatory Affairs Professional Certification preferred.
Other:
- Hybrid role: DC office 2 days/week.
- English proficiency required.
Compensation:
- Salary range: $112,000–$236,000 USD (exact compensation varies by skills, experience, location).
Responsibilities:
- Develop Global/Regional regulatory strategies and implementation plans for complex projects/products (novel, product enhancement, post-approval), optimizing delivery time and success probability.
- Partner with project teams/stakeholders (Clinical, Safety, Medical, GCMC, Quality, R&D, Commercial, Legal) to ensure regulatory contributions (briefing docs, Regulatory Strategy Documents, annual reports, IND/NDA/MAA, etc.) meet quality standards and timelines.
- Provide regulatory input to clinical development programs, risk/benefit assessments, and target label development.
- Support Product Labelling Team: contribute to CCDS development/updates and strategic label input/maintenance.
- Monitor regulatory plans; communicate progress and emerging risks to Senior leadership and mitigate where possible.
- Develop fit-for-purpose submission packages and ensure dossier documentation meets requirements/commitments for Marketing Authorizations.
- Align and champion regulatory positions for key issues; ensure timely, high-quality execution.
- Maintain relationships with Health Authority contacts; lead/participate in agency meetings as appropriate.
- Support regulatory due diligence for business development.
- Ensure adherence to regulatory team processes/systems/working practices/quality standards.
- Implement processes to improve regulatory productivity and enable information sharing across lines.
- Track evolving regulations/guidelines and assess impacts; influence through Health Authority engagement, Country Office partners, and trade associations.
- Ensure business compliance with regulatory standards.
Minimum Qualifications:
- B.S. Scientific Degree required; advanced degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or DMS/MBA preferred.
- 8+ years US/EU/EM Regulatory experience required; 5+ years Global Regulatory experience preferred (education/experience combination considered).
- Relevant Global/Regional regulatory experience; strong knowledge of regulatory environment.
- Proven experience managing global/regional regulatory & registration and/or post-marketing lifecycle; manage complex issues; desirable: multiple products across lifecycle stages.
- Proven time/cost/quality delivery; strong matrix teamwork; strategic thinking.
- Track record negotiating with major Health Authorities, including leading interactions.
- Strong written/verbal communication.
- Regulatory Affairs Professional Certification preferred.
Other:
- Hybrid role: DC office 2 days/week.
- English proficiency required.
Compensation:
- Salary range: $112,000–$236,000 USD (exact compensation varies by skills, experience, location).