Global CMC Lead

3 days ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time

Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative and differentiated antibody therapeutics.

We are seeking a Director/Associate Director to join our Regulatory Affairs CMC team, responsible for providing operational and strategic regulatory CMC input to support worldwide development and commercialization.

This exciting opportunity offers the chance to collaborate with talented and experienced colleagues in Regulatory Affairs as well as within Genmab's CMC organization.

Key responsibilities include:

  • Developing and executing sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle
  • Collaborating with cross-functional peers to facilitate and optimize product development
  • Planning, reviewing and preparing CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages

Required skills and qualifications include a Master of Science in pharmacy, engineering or equivalent, minimum 8+ years of industry experience within Regulatory Affairs CMC, and experience with preparation of BLAs and lifecycle management.



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