Regulatory Affairs CMC Leadership Role

11 hours ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time

At Genmab A/S, we are committed to pushing the boundaries of innovative cancer treatment and serious diseases. Our mission is to develop antibody products that change the lives of patients.

The Regulatory Affairs CMC team at Genmab is a highly trusted partner to our CMC organization. We are seeking a Director/Associate Director to join our dynamic, global company and collaborate with talented colleagues in Regulatory Affairs and CMC.

This exciting opportunity will provide you with the chance to work on operational and strategic regulatory CMC input for worldwide development and commercialization. As a key member of our team, you will be responsible for developing and executing sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle.

You will report to the Senior Director of Regulatory Affairs CMC and be part of a collaborative team consisting of 8 experienced and dedicated colleagues. The position is based in Copenhagen, Denmark, and is hybrid.

About the Role

  • Global Regulatory CMC Strategies: Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle.
  • Cross Functional Collaboration: Collaborate with cross functional peers to facilitate and optimize product development.
  • CMC Documentation: Plan, review, and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
  • Health Authority Interactions: Liaise and negotiate with global health authorities on regulatory CMC topics and represent Genmab at meetings and interactions with health authorities.
  • Regulatory Compliance: Provide advice and guidance on EU, US, and selected worldwide regulatory legislation for CMC topics.
  • Regulatory Risk Management: Evaluate and communicate regulatory risks and challenges.

About You

  • You have a strong understanding of compliance and biologics.
  • You have excellent collaboration and communication skills.
  • You thrive in challenging roles and working in cross-functional teams.
  • You are able to work independently and drive projects to successful outcomes.
  • You have a quality mindset and prioritize your work in a fast-paced environment.
  • You are result-oriented and committed to contributing to the overall success of Genmab.

Why Join Us?

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, our passionate, innovative, and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences.

We are committed to fostering workplace diversity at all levels of the company and believe it is essential for our continued success. We are proud to be an equal opportunities employer.

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