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Global Regulatory Strategy Lead

3 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time
Key Responsibilities
  • Develop and execute global regulatory CMC strategies for biological products during early and late stage development, and lifecycle.
  • Collaborate with cross-functional peers to facilitate and optimize product development.
  • Plan, review, and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
  • Prepare responses to health authority information requests.
  • Plan and prepare post-approval applications.
  • Provide advice and guidance on EU, US, and selected worldwide regulatory legislation for CMC topics.
  • Evaluate and communicate regulatory risks and challenges.
  • Liaise and negotiate with global health authorities on regulatory CMC topics and represent Genmab at meetings and interactions with health authorities.
Requirements
  • Masters degree in pharmacy, engineering, or equivalent.
  • Minimum 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).