Genmab

Associate Director, Global Regulatory Affairs, CMC

Genmab

full-time

Posted on:

Location Type: Hybrid

Location: Copenhagen • Denmark

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Job Level

Senior

About the role

  • Provide strategic and operational regulatory CMC expertise across global development projects
  • Develop and execute global regulatory CMC strategies for biological products
  • Collaborate with cross-functional colleagues to optimize product development
  • Plan and prepare CMC documentation for clinical applications

Requirements

  • Master of Science in pharmacy, engineering or equivalent
  • Minimum 5-10 years of industry experience within Regulatory Affairs CMC
  • Strong understanding of compliance and biologics
  • Proficient communication in English (verbal and written)
Benefits
  • Hybrid work model
  • Collaborative team environment
  • Opportunity to work on innovative projects
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory CMC expertiseglobal regulatory CMC strategiesCMC documentationbiological products
Soft Skills
collaborationcommunication
Certifications
Master of Science in pharmacyMaster of Science in engineering