Director Respiratory Regulatory CMC
Location
hatfield, england
Job Type
Full-time
Category
Management & Operations
Posted
June 20, 2026
Mylan Pharma UK Limited
The Role & What You Will Be Doing
- Cultivates sustainable & effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.
- Uses technical and scientific knowledge in the preparation and analysis of global CMC submission documentation and maintenance of product compliance and management of CMC change control. Guides preparation of CMC submission documentation where assigned.
- Serves as a liaison with regulatory agencies for specific topics and providing oversight for the fulfillment of agency commitments and providing responses to agency queries. Responsibilities include the lead in preparations and interactions for regulatory authority meetings.
- Manages, leads and contributes significantly to the respiratory portfolio, individual projects and initiatives within cross‑functional project teams.
- Pa...