Director, Global Regulatory Strategist - Allergy/Cardiovascular Portfolio

Responsibilities

• Develop and implement global and regional regulatory strategies for complex Allergy and Cardiovascular projects, including novel products and post-approval enhancements.
• Provide regulatory input for clinical development programs, risk/benefit assessments, and target label development.
• Serve as a member of the Product Labelling Team to contribute to the development and update of the CCDS and local labels.
• Cultivate effective relationships with internal stakeholders and external Health Authority contacts to drive aligned regulatory approaches.
• Monitor regulatory plans, communicate progress to Senior Management, and mitigate risks from emerging technical data or changing regulations.
• Direct the preparation of high-quality documentation and author sections of dossiers to secure Marketing Authorizations.
• Support regulatory due diligence activities for business development opportunities.

Requirements

• Bachelor's degree or equivalent (Advanced scientific or business degrees such as Ph.D., Pharm.D., or MBA are a plus).
• Minimum of 8 years in regulatory affairs with at least 5 years of global regulatory experience (US/EU).
• 5+ years of experience in global regulatory strategy and hands-on dossier authoring.
• 5+ years of experience in project management, managing matrixed teams, or people management.
• Deep knowledge of the drug development lifecycle and the ability to assess clinical and scientific data.
• Proficiency in Microsoft Office Suite and English fluency (written and oral).

Preferred Qualifications

• Specialized knowledge of Allergy and Cardiovascular therapeutic areas.
• Regulatory Affairs Professional Certification.
• Experience leading negotiations and direct interactions with global regulatory authorities.

About the Company

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands. Our mission is to empower people worldwide to live healthier at every stage of life by providing access to high-quality medicines for approximately 1 billion patients annually.