Senior Specialist, Global Regulatory Affairs CMC

Senior Specialist, Global Regulatory Affairs CMC

Are you motivated about navigating the complex world of regulatory affairs? We are seeking a skilled and passionate Regulatory CMC Senior Specialist 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.

Your new role – why is this a great opportunity?

The Senior Specialist, Global Regulatory Affairs CMC will support regulatory CMC activities for multiple Lundbeck products.  The Senior Specialist 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 Senior Specialist will need to efficiently coordinate multiple projects in a fast and results-oriented environment to deliver transformative medicines for patients and will be based at the Valby site.

Your future team

As our Senior Specialist, Global Regulatory Affairs CMC, you will join a team focused on RA CMC Strategy. We are working on creative, high-profile projects that aim at making Lundbeck #1 in brain health. We are enthusiastic about what we do, and we also make time to have fun together.

Some of your the tasks and responsibilities include

• Provide RA-CMC strategic input to Product Development and Supply and to other regulatory functions for both marketed and development products/programs
• Act as advisor on RA-CMC related issues for Product Development and Supply
• Ensure regulatory requirements are met and at the same time ensure Lundbeck's interest to the highest possible extent
• Provide RA-CMC input to planning and preparation for all submissions with CMC content, e.g.:
• 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
• Obtain/maintain knowledge on relevant regulatory legislation, guidelines and trends

What you bring to the team

• BA/BS degree in a scientific/engineering discipline
• 15+ years of experience in the pharmaceutical industry
• Experience with CTD format and content regulatory filings including NDA and MAA
• Effective communication and interpersonal skills to effectively collaborate with cross-functional teams and external stakeholders.
• Informal approach to stakeholders and colleagues

Our promise to you  

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

You can also learn more about us at www.lundbeck.com or by following us on LinkedIn, Instagram (@h_lundbeck) or Twitter (@Lundbeck).

Apply now

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. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions or want to hear more, please feel free to contact Paul Dawidczyk PADW@lundbeck.com. Applications must be received by 31-Jan-26.

We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.

#EveryBrainInTheGame

To external agencies: Lundbeck does not accept unsolicited requests or candidates from search firms. We ask you to respect this policy by refraining from contacting our employees about this position.