Director Regulatory Affairs CMC Biosimilars

This is an international recruitment process. Please apply only through https://recruitmentsuisse.com/director-regulatory-affairs-cmc-biosimilars-job-SjAwNzk4

Your assignments

• 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

Your profile