Director Regulatory Affairs CMC Biosimilars
- Provides global leadership regarding management of submission CMC related documents and CMC regulatory data for Biosimilars.
- Develops CMC regulatory strategy for assigned projects
- As Business partner to the Biosimilar CMC team develops, supervises and manages the CMC regulatory activities and CMC submission strategy of Biosimilar dossiers and submissions that best serve the biosimilars business needs.
- Translate CMC data in regulatory CMC positioning to create a comprehensive story line and CMC dossier
- Act as RA CMC lead for development projects
- Manage, supervise and develop senior managers for assigned projects
- Degree in a Life Science or related discipline and possible higher degree
- At least 10 years pharmaceutical experience of which at least 8 years in international regulatory with focus on CMC in Biologics
- Experience in managing a full initial marketing application submission or IMPD/INDs
- Experience in preparation and coordination of regulatory strategy plans
- Experience in interaction with regulatory agency in agency meetings for the major agencies (EMA/FDA)
- Experience in analytics or drug substance process development for new biological entities
- Experience in development of new biologicals or biosimilars
Job-specific competencies & skills
- Excellent spoken and written English. A second major language would be an advantage.
- Excellent written and spoken communication skills
- Excellent interpersonal skills
- Understanding of Regulatory Affairs contribution to Pharma business
- Good organizational and planning skills
- Ability to think strategically
- Ability to lead and work in teams