Global CMC Strategy Leader

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time

About Us

At Genmab, we're passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment. We believe in being proud of our uniqueness, determined to be our best, and authentic in all that we do.

Job Description

We're seeking an exceptional individual to join our Regulatory Affairs CMC team as a Director/Associate Director. The role involves developing and executing global regulatory CMC strategies, collaborating with cross-functional peers, and preparing CMC documentation for various applications.

Key Responsibilities

  • Develop and execute regulatory CMC strategies for biological products.
  • Collaborate with cross-functional teams to optimize product development.
  • Prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
  • Liaise and negotiate with global health authorities on regulatory CMC topics.
  • Remain informed on regulatory laws and guidances.

Requirements

  • Master of Science in pharmacy, engineering or equivalent.
  • Minimum of 8+ years of industry experience within Regulatory Affairs CMC, with a strong understanding of compliance and biologics.
  • A track record in moving therapeutic products through various stages of development.
  • Experience with preparation of BLAs and preferably experience with lifecycle management.
  • Proficient communication in English (verbal and written).


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