Global Regulatory Affairs Specialist

3 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
Regulatory Submission Manager Position

We seek an experienced Regulatory Submission Manager to manage submissions for MAA, BLA, and IND applications, collaborate with cross-functional teams, and drive timely delivery of submission documents.

Key Responsibilities
  • Oversee submission management to ensure compliance and accuracy
  • Develop and maintain relationships with project managers, regulatory leaders, and content authors to facilitate submission preparation
  • Represent Regulatory Operations on project teams to drive project goals and objectives

The successful candidate will possess excellent communication and leadership skills, as well as in-depth knowledge of regulatory requirements and industry standards. Reporting to the Senior Director of Global Regulatory Affairs, Operations.

Essential Qualifications
  • Minimum 5 years pharmaceutical industry experience, with a focus on Regulatory Operations
  • BA/BS degree or equivalent and knowledge of MAA/BLA/IND requirements and guidelines
  • Proficiency with MS-Office Suite and Adobe Acrobat application
Why Join Us

Genmab is a dynamic and innovative biotechnology company committed to delivering life-changing treatments. As a member of our team, you will have access to cutting-edge technologies, opportunities for professional growth, and a competitive compensation package.



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