Director, Global Regulatory Strategist -Allergy/Cardiovascular Portfolio
Viatris
13 hours ago
Remote friendly (Washington, DC)
United States
$112,000 - $236,000 USD yearly
Corporate Functions
Key Responsibilities:
- Develop and implement global/regional regulatory strategies and plans for Allergy and Cardiovascular projects/products (novel, enhancements, post-approval), optimizing delivery timelines and success probability.
- Provide regulatory input to clinical development, risk/benefit assessments, and target label development.
- Ensure aligned regulatory positions for key issues; champion, communicate, and execute positions on time and to required quality standards.
- Contribute to CCDS development/update (Product Labelling Team) and support local label maintenance as appropriate.
- Monitor regulatory plans; communicate progress and mitigate emerging risks.
- Lead preparation of high-quality regulatory documentation to support Marketing Authorizations (including dossier authoring sections as applicable).
- Manage Health Authority relationships; organize/lead/participate in regulatory meetings; ensure submission and interaction quality.
- Stay current on evolving regulations/guidelines and influence the environment via Health Authority engagement and partner/trade association activities.
- Support regulatory due diligence for business development; provide input to and adhere to departmental budget.
Qualifications & Required/Preferred Skills:
- BS required; advanced degree (Ph.D./Pharm.D./M.D./M.Sc.) and/or business qualification (DMS/MBA) preferred.
- 8+ years regulatory experience; 5+ years global regulatory (US/EU).
- 5+ years global regulatory strategy and hands-on authoring (initial registrations/post-approval variations).
- Strong written/oral communication; Microsoft Office and Documentum-based applications.
- Advanced understanding of global regulatory requirements and leading Health Authority negotiations/interactions.
- Partnering ability across regulatory/clinical/non-clinical/safety/medical/commercial/R&D/legal; proven delivery to time/cost/quality.
- Experience managing projects/matrix teams and/or people leadership (5+ years) preferred; Allergy and Cardiovascular therapeutic area experience preferred.
- Individual contributor autonomy; regulatory professional certification preferred; English proficiency required.
- Develop and implement global/regional regulatory strategies and plans for Allergy and Cardiovascular projects/products (novel, enhancements, post-approval), optimizing delivery timelines and success probability.
- Provide regulatory input to clinical development, risk/benefit assessments, and target label development.
- Ensure aligned regulatory positions for key issues; champion, communicate, and execute positions on time and to required quality standards.
- Contribute to CCDS development/update (Product Labelling Team) and support local label maintenance as appropriate.
- Monitor regulatory plans; communicate progress and mitigate emerging risks.
- Lead preparation of high-quality regulatory documentation to support Marketing Authorizations (including dossier authoring sections as applicable).
- Manage Health Authority relationships; organize/lead/participate in regulatory meetings; ensure submission and interaction quality.
- Stay current on evolving regulations/guidelines and influence the environment via Health Authority engagement and partner/trade association activities.
- Support regulatory due diligence for business development; provide input to and adhere to departmental budget.
Qualifications & Required/Preferred Skills:
- BS required; advanced degree (Ph.D./Pharm.D./M.D./M.Sc.) and/or business qualification (DMS/MBA) preferred.
- 8+ years regulatory experience; 5+ years global regulatory (US/EU).
- 5+ years global regulatory strategy and hands-on authoring (initial registrations/post-approval variations).
- Strong written/oral communication; Microsoft Office and Documentum-based applications.
- Advanced understanding of global regulatory requirements and leading Health Authority negotiations/interactions.
- Partnering ability across regulatory/clinical/non-clinical/safety/medical/commercial/R&D/legal; proven delivery to time/cost/quality.
- Experience managing projects/matrix teams and/or people leadership (5+ years) preferred; Allergy and Cardiovascular therapeutic area experience preferred.
- Individual contributor autonomy; regulatory professional certification preferred; English proficiency required.