Global Regulatory Affairs Leader

6 days ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time
Job Description

We are looking for a skilled Director/Associate Director to join our Regulatory Affairs CMC team in Copenhagen, Denmark.

You will be responsible for operational and strategic regulatory CMC input to support worldwide development and commercialization of biological products. Your main duties will include developing and executing sound global regulatory CMC strategies, collaborating with cross-functional peers, and providing advice on EU, US, and selected worldwide regulatory legislation.

Responsibilities:
  1. Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle
  2. Collaborate with cross functional peers to facilitate and optimize product development
  3. Plan, review and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages


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