Director, Global Regulatory Strategist -Allergy/Cardiovascular Portfolio
Viatris
August 30, 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 enhancement, and 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 CCDS development/update and maintain local labels as appropriate (Product Labelling Team).
- Cultivate relationships with stakeholders/partners/customers to drive aligned regulatory strategies/policies.
- Monitor regulatory plans; communicate progress to Senior Management; mitigate risks.
- Ensure high-quality regulatory documentation and commitments for Marketing Authorizations (author dossier sections as applicable).
- Build relationships with Health Authority contacts; lead/participate in agency meetings; ensure submission interaction quality expectations.
- Adhere to consistent regulatory processes/systems/quality standards.
- Stay current on evolving regulations; influence 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 scientific/business degrees preferred but not essential).
- 8+ years regulatory experience; 5+ years global regulatory experience (US/EU).
- 5+ years Global Regulatory Affairs strategy with hands-on authoring (initial registrations/post-approval variations).
- Strong knowledge of development & commercial activities; focus on Allergy and Cardiovascular.
- Advanced regulatory knowledge; experience leading negotiations/interactions with authorities.
- Ability to partner across Regulatory, Clinical, Non-Clinical, Safety, Medical, Commercial, R&D, Legal, and senior stakeholders.
- Advanced written/oral communication.
- Microsoft Office Suite and Documentum.
- 5+ years managing projects/matrix teams and/or people management.
- Ability to participate in authority interactions.
Preferred:
- Allergy and Cardiovascular therapeutic area experience; Regulatory Affairs professional certification.
Application/Other:
- Functions autonomously with minimal supervision; English proficiency required.
- Develop global/regional regulatory strategies and implementation plans for Allergy and Cardiovascular complex projects/products (novel, product enhancement, and 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 CCDS development/update and maintain local labels as appropriate (Product Labelling Team).
- Cultivate relationships with stakeholders/partners/customers to drive aligned regulatory strategies/policies.
- Monitor regulatory plans; communicate progress to Senior Management; mitigate risks.
- Ensure high-quality regulatory documentation and commitments for Marketing Authorizations (author dossier sections as applicable).
- Build relationships with Health Authority contacts; lead/participate in agency meetings; ensure submission interaction quality expectations.
- Adhere to consistent regulatory processes/systems/quality standards.
- Stay current on evolving regulations; influence 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 scientific/business degrees preferred but not essential).
- 8+ years regulatory experience; 5+ years global regulatory experience (US/EU).
- 5+ years Global Regulatory Affairs strategy with hands-on authoring (initial registrations/post-approval variations).
- Strong knowledge of development & commercial activities; focus on Allergy and Cardiovascular.
- Advanced regulatory knowledge; experience leading negotiations/interactions with authorities.
- Ability to partner across Regulatory, Clinical, Non-Clinical, Safety, Medical, Commercial, R&D, Legal, and senior stakeholders.
- Advanced written/oral communication.
- Microsoft Office Suite and Documentum.
- 5+ years managing projects/matrix teams and/or people management.
- Ability to participate in authority interactions.
Preferred:
- Allergy and Cardiovascular therapeutic area experience; Regulatory Affairs professional certification.
Application/Other:
- Functions autonomously with minimal supervision; English proficiency required.