Regulatory Affairs Director: Transforming Cancer Treatment with Antibody Therapeutics

3 days ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time

At Genmab A/S, we're seeking a highly skilled Director/Associate Director to join our Regulatory Affairs CMC team. As a key player in our global development and commercialization efforts, you will drive operational and strategic regulatory CMC initiatives.

About the Role

The ideal candidate will have a strong understanding of compliance and biologics, with a proven track record in moving therapeutic products through various stages of development. You will be responsible for developing and executing sound global regulatory CMC strategies for biological products, collaborating with cross-functional peers, and preparing CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.

We offer an exciting and challenging role in a dynamic, global company, with a hybrid work environment based in Copenhagen, Denmark. As a member of our Regulatory Affairs CMC team, you will contribute to our mission to transform the lives of patients through innovative cancer treatment.

Key Responsibilities
  • Develop and execute global regulatory CMC strategies for biological products during early and late-stage development and lifecycle management.
  • Collaborate with cross-functional teams to facilitate and optimize product development.
  • Prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
  • Plan and prepare responses to health authority information requests and 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.
About Genmab A/S

Genmab is an international biotechnology company committed to improving the lives of patients through innovative antibody therapeutics. Our passionate, innovative, and collaborative team has invented next-generation antibody technology platforms, leveraging translational research and data sciences.

We are dedicated to fostering workplace diversity and believe it is essential for our continued success. We are an equal opportunities employer and welcome applications from diverse candidates.

Benefits and Perks

We offer a competitive salary range of 120,000 - 180,000 DKK per year, depending on experience, as well as additional benefits, including health insurance, retirement plan, and professional development opportunities.



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