Director, Global Regulatory Strategist -Allergy/Cardiovascular Portfolio
Viatris
June 26, 2026
Remote friendly (Washington, DC)
United States
Corporate Functions
Key responsibilities:
- Develop global/regional regulatory strategies and implementation plans for Allergy and Cardiovascular complex projects/products (novel, product enhancements, post-approval); optimize delivery time and probability of success.
- Provide regulatory input to clinical development, risk/benefit assessments, and target label development.
- Ensure aligned regulatory positions for key issues; champion, communicate, and execute on time to required quality standards.
- Support Product Labelling Team: contribute to CCDS development/updates and local label development/maintenance as appropriate.
- Build effective stakeholder/partner/customer relationships to drive aligned regulatory strategies and/or policies.
- Monitor regulatory plans; communicate progress to Senior Management and mitigate emerging risks.
- Prepare high-standard documentation and ensure regulatory requirements/commitments for Marketing Authorizations (including dossier author sections as applicable).
- Maintain relationships with Health Authorities; organize/lead/participate in agency meetings; ensure quality expectations for submissions/interactions.
- Collaborate within Regulatory to ensure consistent processes, systems, working practices, shared learnings, and quality standards.
- Interpret evolving global/regional regulations and assess impact; influence environment via Health Authority engagement, partners, and trade associations.
- Support regulatory due diligence for business development.
- Provide input to and adhere to departmental budget.
Minimum qualifications:
- Bachelor’s degree (advanced degree/business qualification a plus).
- 8+ years regulatory experience; 5+ years global regulatory experience (US/EU).
- 5+ years global regulatory strategy and hands-on authoring (initial registrations/post-approval variations).
- Strong knowledge of development & commercial activities; focus on Allergy and Cardiovascular.
- Advanced regulatory requirements knowledge; lead negotiations/interactions with authorities.
- Partner effectively across functions (Clinical, Safety, Medical, Commercial, R&D, Legal) and senior stakeholders; deliver to time/cost/quality.
- Advanced written/oral communication skills; Microsoft Office and Documentum.
- 5+ years managing projects/matrixed teams and/or people leadership (preferred/required as stated).
- Allergy and Cardiovascular therapeutic area knowledge advantageous.
As an individual contributor:
- Functions autonomously with minimal supervision.
- Regulatory Affairs Professional Certification preferred.
Compensation:
- Salary range: $112,000–$236,000 USD (exact compensation varies).
Application instructions:
- Not provided in the text.
- Develop global/regional regulatory strategies and implementation plans for Allergy and Cardiovascular complex projects/products (novel, product enhancements, post-approval); optimize delivery time and probability of success.
- Provide regulatory input to clinical development, risk/benefit assessments, and target label development.
- Ensure aligned regulatory positions for key issues; champion, communicate, and execute on time to required quality standards.
- Support Product Labelling Team: contribute to CCDS development/updates and local label development/maintenance as appropriate.
- Build effective stakeholder/partner/customer relationships to drive aligned regulatory strategies and/or policies.
- Monitor regulatory plans; communicate progress to Senior Management and mitigate emerging risks.
- Prepare high-standard documentation and ensure regulatory requirements/commitments for Marketing Authorizations (including dossier author sections as applicable).
- Maintain relationships with Health Authorities; organize/lead/participate in agency meetings; ensure quality expectations for submissions/interactions.
- Collaborate within Regulatory to ensure consistent processes, systems, working practices, shared learnings, and quality standards.
- Interpret evolving global/regional regulations and assess impact; influence environment via Health Authority engagement, partners, and trade associations.
- Support regulatory due diligence for business development.
- Provide input to and adhere to departmental budget.
Minimum qualifications:
- Bachelor’s degree (advanced degree/business qualification a plus).
- 8+ years regulatory experience; 5+ years global regulatory experience (US/EU).
- 5+ years global regulatory strategy and hands-on authoring (initial registrations/post-approval variations).
- Strong knowledge of development & commercial activities; focus on Allergy and Cardiovascular.
- Advanced regulatory requirements knowledge; lead negotiations/interactions with authorities.
- Partner effectively across functions (Clinical, Safety, Medical, Commercial, R&D, Legal) and senior stakeholders; deliver to time/cost/quality.
- Advanced written/oral communication skills; Microsoft Office and Documentum.
- 5+ years managing projects/matrixed teams and/or people leadership (preferred/required as stated).
- Allergy and Cardiovascular therapeutic area knowledge advantageous.
As an individual contributor:
- Functions autonomously with minimal supervision.
- Regulatory Affairs Professional Certification preferred.
Compensation:
- Salary range: $112,000–$236,000 USD (exact compensation varies).
Application instructions:
- Not provided in the text.