Regulatory Compliance Process Lead

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're dedicated to developing life-changing antibody products that transform cancer treatment and serious diseases. With a strong commitment to our purpose and rooted-in-science approach, we strive for excellence in everything we do.

About the Role

This is a unique opportunity to join our team as a Regulatory Compliance Process Lead, focusing on the development and management of Standard Operating Procedures (SOPs) for the Global Regulatory Affairs organization. You will be responsible for ensuring regulatory audit and inspection readiness, providing expertise through project management, and driving training completion compliance across the organization.

Key Responsibilities
  • Lead the Regulatory Affairs Process Expert Group (PEG)
  • Develop and maintain SOPs and Work Instructions (WIs)
  • Ensure regulatory audit and inspection readiness
  • Drive training completion compliance

We're seeking an experienced professional with 6-8 years of experience in EU, RoW, and/or US regulatory compliance or similar functions at pharmaceutical companies. If you have a proven track record of managing multiple tasks, applying organizational and prioritization skills, and driving results-oriented projects, we want to hear from you

Why Join Us?
  • You'll be part of a collaborative team that's passionate about improving patient lives.
  • You'll have the opportunity to work on innovative projects that drive change in cancer treatment and serious diseases.
  • You'll enjoy a hybrid work arrangement, splitting time between our Copenhagen HQ and remote work.
Salary: €80,000 - €110,000 per annum

Based on your experience and qualifications, you can expect a competitive salary within this range. We're committed to recognizing and rewarding outstanding performance.



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