SCIENTIST, GLOBAL REGULATORY AFFAIRS CMC

Are you motivated about navigating the complex world of regulatory affairs? We are seeking a skilled and passionate Regulatory CMC Scientist to join our global team. This is a newly created role within the RA CMC organization as we continue to build our global RA CMC organization.

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Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!
Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.
If you have questions, please contact Paul Dawidczyk PADW@lundbeck.com.
Applications must be received by 30 September 2025.
Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).

EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

The Scientist, Global Regulatory Affairs CMC will support regulatory CMC activities for multiple Lundbeck products. The Scientist will provide input on regulatory CMC strategy and collaborate with key stakeholders to prepare regulatory submissions and Health Authority communications in alignment with the regulatory CMC strategy. The Scientist will need to efficiently coordinate multiple projects in a fast and results-oriented environment to deliver transformative medicines for patients.

Some of your the tasks and responsibilities include:

• Review CMC documents for submissions as relevant
• Review Change Requests
• Prepare and update Master Submission index for module 3/ASMF’s/DMF’s
• Prepare and update Quality Overall Summaries (for mature products)
• Prepare CMC related administrative documents for submissions as relevant
• Prepare responses to CMC related authority questions
• Comment on guidelines and pharmacopoeia monographs