Director of Regulatory Strategy and Operations

2 days ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time
Regulatory Affairs Expertise for a Leading Biotech Company

We are seeking a highly experienced and skilled Director of Regulatory Strategy and Operations to join our team at Genmab A/S. As a key member of the Global Regulatory Affairs organization, you will play a critical role in shaping the company's regulatory strategies and ensuring the successful execution of global submissions.

About the Role

The ideal candidate will have significant experience in regulatory affairs, with expertise in drug development and EU regulatory mechanisms to expedite development. Prior experience leading health authority meetings with the EMA or other health authorities is highly desirable.

You will work closely with cross-functional teams, including Development, Commercial, and Manufacturing, to develop and implement global regulatory strategies that meet the company's business objectives. Your expertise will be invaluable in navigating the complex regulatory landscape and ensuring compliance with all relevant requirements.

This is an exciting opportunity for a seasoned regulatory professional to make a meaningful contribution to Genmab's continued growth and success.

Responsibilities Include:

  • Leadership of cross-functional teams to execute global submissions.
  • Development and implementation of global regulatory strategies.
  • Regulatory CRO oversight.
  • Strategic planning and execution.


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