Regulatory Strategy Lead
5 days ago
Genmab is committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success.
We're seeking a Regulatory Strategy Lead to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible for operational and strategic regulatory CMC input to support worldwide development and commercialization.
You will report to the Senior Director of Regulatory Affairs CMC and be part of a robust and supportive team fostering a culture of collaboration and mutual support.
The position is based in Copenhagen, Denmark and is hybrid. You will work collaboratively with talented and experienced colleagues in Regulatory Affairs as well as within Genmab's CMC organization.
Key Responsibilities- Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle.
- Collaborate with cross-functional peers to facilitate and optimize product development.
- Plan, review and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
- Master of Science in pharmacy, engineering or equivalent.
- Minimum of 8+ years of industry experience within Regulatory Affairs CMC, with a strong understanding of compliance and biologics.
- A track record in moving therapeutic products through various stages of development.
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at . Associate Director, EU/ROW Regulatory Lead page is loaded Associate Director, EU/ROW Regulatory Lead Apply locations Copenhagen time type Full time posted on ...
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