Job Information
Lundbeck Senior Specialist, Global Regulatory Affairs CMC in Copenhagen, Denmark
Senior Specialist, Global Regulatory Affairs CMC
Requisition ID: 7527
Location:
Copenhagen, Danish Capital Region, DK
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
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
The position is based in Copenhagen, Denmark.
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 and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.
We need every brain in the game, and at Lundbeck, 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 .
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 30 April 2026.
Learn more about us at www.lundbeck.com ,LinkedIn (https://www.linkedin.com/company/lundbeck/) 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
About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.