Director, Global Regulatory Strategist -Allergy/Cardiovascular Portfolio
Viatris
August 08, 2026
On-site
Washington, DC
Corporate Functions
Key Responsibilities:
- Develop Global/Regional regulatory strategies and implementation plans for Allergy and Cardiovascular complex projects/products (novel, product enhancements, post-approval).
- Provide regulatory input to clinical development programs, risk/benefit assessments, and target label development.
- Ensure aligned regulatory positions for key issues; champion, communicate, and execute on time to required quality standards.
- Contribute to development/update of CCDS and support local label development/maintenance as appropriate.
- Build sustainable relationships across stakeholders, partners, and customers to align regulatory strategies/policies.
- Monitor regulatory plans; communicate progress to Senior Management; mitigate risks.
- Prepare high-quality regulatory documentation and meet requirements/commitments for Marketing Authorizations (including dossier authoring as applicable).
- Manage relationships with Health Authority contacts; organize/lead/participate in agency meetings; ensure submission/interaction quality expectations.
- Adhere to consistent Regulatory processes/systems/quality standards; share learnings with the team.
- Stay current on global/regional regulations and assess impact; influence evolving environment via Health Authority engagement/partners/trade associations.
- Support regulatory due diligence for business development.
- Provide input to and adhere to departmental budget.
Minimum Qualifications:
- Bachelor’s degree (or equivalent); advanced scientific degree and/or business qualification a plus.
- 8+ years regulatory experience; 5+ years global regulatory experience (US/EU).
- 5+ years global Regulatory Affairs strategy with hands-on authoring (initial registrations or post-approval variations).
- Strong knowledge of development & commercial activities with focus on Allergy and Cardiovascular.
- Advanced understanding of global emerging regulatory requirements; lead negotiations/interactions with authorities.
- Partner effectively across functions (Clinical, Non-Clinical, Safety, Medical, Commercial, R&D, Legal, seniors).
Preferred/Skills:
- Allergy/Cardiovascular therapeutic area experience.
- Advanced written/oral communication.
- Microsoft Office and Documentum.
- 5+ years managing projects/matrix teams and/or people management.
- Ability to respond to regulatory authority requests.
- Strategic thinking; deliver to time/cost/quality.
As an Individual Contributor:
- Works autonomously with minimal supervision.
- Regulatory Affairs Professional Certification preferred.
- English proficiency.
Compensation:
- Salary range: $112,000–$236,000 USD (exact compensation varies by skills/experience/location).
- Develop Global/Regional regulatory strategies and implementation plans for Allergy and Cardiovascular complex projects/products (novel, product enhancements, post-approval).
- Provide regulatory input to clinical development programs, risk/benefit assessments, and target label development.
- Ensure aligned regulatory positions for key issues; champion, communicate, and execute on time to required quality standards.
- Contribute to development/update of CCDS and support local label development/maintenance as appropriate.
- Build sustainable relationships across stakeholders, partners, and customers to align regulatory strategies/policies.
- Monitor regulatory plans; communicate progress to Senior Management; mitigate risks.
- Prepare high-quality regulatory documentation and meet requirements/commitments for Marketing Authorizations (including dossier authoring as applicable).
- Manage relationships with Health Authority contacts; organize/lead/participate in agency meetings; ensure submission/interaction quality expectations.
- Adhere to consistent Regulatory processes/systems/quality standards; share learnings with the team.
- Stay current on global/regional regulations and assess impact; influence evolving environment via Health Authority engagement/partners/trade associations.
- Support regulatory due diligence for business development.
- Provide input to and adhere to departmental budget.
Minimum Qualifications:
- Bachelor’s degree (or equivalent); advanced scientific degree and/or business qualification a plus.
- 8+ years regulatory experience; 5+ years global regulatory experience (US/EU).
- 5+ years global Regulatory Affairs strategy with hands-on authoring (initial registrations or post-approval variations).
- Strong knowledge of development & commercial activities with focus on Allergy and Cardiovascular.
- Advanced understanding of global emerging regulatory requirements; lead negotiations/interactions with authorities.
- Partner effectively across functions (Clinical, Non-Clinical, Safety, Medical, Commercial, R&D, Legal, seniors).
Preferred/Skills:
- Allergy/Cardiovascular therapeutic area experience.
- Advanced written/oral communication.
- Microsoft Office and Documentum.
- 5+ years managing projects/matrix teams and/or people management.
- Ability to respond to regulatory authority requests.
- Strategic thinking; deliver to time/cost/quality.
As an Individual Contributor:
- Works autonomously with minimal supervision.
- Regulatory Affairs Professional Certification preferred.
- English proficiency.
Compensation:
- Salary range: $112,000–$236,000 USD (exact compensation varies by skills/experience/location).