Regulatory Compliance Process Lead
2 weeks ago
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 RoleThis 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.
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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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout GenmabGenmab is a pioneering biotechnology company dedicated to developing innovative antibody therapies that transform the lives of patients with cancer and other serious diseases. Our mission is to push the boundaries of science and medicine, and our team is passionate about making a meaningful impact.The RoleWe are seeking a highly skilled and...
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