28/09/2021
Applications are accepted only at https://recruitmentsuisse.com/director-regulatory-affairs-cmc-biosimilars-job-SjAwNzk4
Job Overview
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
Education
Degree in a Life Science or related discipline and possible higher degree
Work experience
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
