Associate Director of Global Regulatory Compliance

5 days ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time

Our Regulatory Affairs organization plays a critical role in ensuring the successful development and approval of our innovative antibody products and therapies. As our Senior Manager EU/ROW Regulatory Affairs, you'll have the opportunity to make a significant impact on our regulatory strategy and compliance efforts.

You'll work closely with cross-functional teams, including Clinical Trials, Compound Development, and Global Regulatory, to ensure that our regulatory plans are aligned with business objectives and that we're meeting our regulatory obligations. Your expertise will be invaluable in developing and executing EU/ROW regulatory strategies, and in providing guidance on procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team.

We're looking for someone with a strong background in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications. Prior experience leading health authority meetings with the EMA or other health authorities is essential, as well as a good understanding of drug development and EU regulatory procedures. Experience within oncology and/or I&I will be a plus, as will experience with PIPs and development and regulatory requirements in ROW markets.



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