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Regulatory Affairs Director

3 weeks ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time
About the Job

Genmab A/S is seeking a seasoned Regulatory Affairs professional to lead its Global Regulatory Affairs organization. The successful candidate will be responsible for developing and executing global regulatory strategies, ensuring operational execution of submission activities, and interfacing with EMA as primary contact for assigned programs.

This leadership role involves overseeing CRO quality, accountabilities, and deliverables related to Regulatory activities. The individual will assess EU and MHRA regulatory guidelines and regulations, evaluate regulatory mechanisms for optimizing product development, and ensure compliance with internal and external requirements.

The ideal candidate will have significant experience in proactively planning and implementing complex clinical submission strategies, leading a team of regulatory strategist professionals, and collaborating with health authorities. Prior experience leading health authority meetings with the EMA or other health authorities is preferred.