Principal Professional RA CMC

Application deadline: 28-APRIL-2026 
Location: Ballerup 2750, Denmark, Denmark 
Contract type: Permanent 
Job ID: 4370 

Are you ready to step into a highly strategic and scientifically strong role within Regulatory Affairs? We are looking for a Principal Professional, RA CMC to drive RA CMC strategic activities during development, providing strategic leadership and operational support to assigned early development programs.  As part of our RA CMC & Device team in Ballerup, Denmark, you will play a critical role in development of multiple early assets, defining regulatory strategies to secure a globally appropriate development approach, and securing fast approvals for regulatory submissions. If you are passionate about shaping global regulatory strategies and securing development whilst working with a wide range of engaged stakeholders globally, we’d love to hear from you!

Join us in creating a future legacy in medical dermatology.

At LEO Pharma, we are global leaders in medical dermatology. We have 115 years' experience bringing innovation to healthcare and improving the quality of life for patients worldwide.

Your Role

As a Principal Professional, RA CMC, you will act as a trusted leader, providing cross-functional regulatory guidance and leading CMC-related regulatory strategies for product development of early phase biological and small molecule projects, including for Business Development activities. You will work closely with stakeholders across Global Regulatory Affairs and Product Supply, ensuring alignment and delivering high-quality submissions to regulatory authorities globally.

Your key responsibilities include:

• Leading and delivering CMC regulatory input to the Global Regulatory Strategy (GRS) in collaboration with the Global Regulatory Team and relevant stakeholders.
• Lead and facilitate CMC-related Health Authority interactions during Development including preparation of Briefing Packs, preparing regulatory documentation to support Clinical Trials, and ensuring compliance with global regulatory requirements.

• Proactively identify program issues and develop regulatory strategies to mitigate risks to filings; find alternative solutions/workarounds and secure interpersonal consensus.
• Ensuring flexibility in regulatory dossiers to support post-approval planning and operations for Global Product Supply (GPS).
• Keeping up-to-date with Regulatory Intelligence (RI) and providing strategic insights to guide regulatory CMC strategies.
• Independently assessing and providing regulatory advice on Change Control cases.
• Acting as a coach and mentor for colleagues and participating in cross-functional improvement projects.
• Representing LEO Pharma in industry associations and working groups to stay at the forefront of regulatory developments.

Your Qualifications

To excel in this role, you should bring:

• A Master’s or Bachelor’s degree in pharmaceutics, biomedicine, chemical engineering, or a related scientific field.
• Over 8 years of experience in Regulatory Affairs, preferably within the CMC biologics area of the pharmaceutical or biopharmaceutical industry. Additional small molecules experience would be highly valuable.
• Experience supporting combination products through development and approval.
• Strong development experience including driving RA CMC strategic activities during development, including preparation for clinical trial submissions and global Health Authority interactions in anticipation of a marketing authorization application
• Proven experience in preparing, submitting, and gaining approval for CMC/device documents across global markets.
• Demonstrated ability to lead and manage complex regulatory projects effectively.
• Extensive knowledge of global CMC guidelines and their application throughout development and the drug lifecycle.
• Strong understanding of drug development processes, lifecycle management, and the strategic implications of scientific discussions on regulatory strategies.
• Experience in cross-functional collaboration with RA, Product Supply, and Quality teams.
• A strategic mindset with effective critical thinking, strong problem-solving, and risk mitigation skills.
•  Excellent communication, negotiation, and interpersonal  abilities  to align cross-functional teams and ensure effective decision-making.
• Experience in development for rare diseases is an advantage.

Your New Team

As part of the RA CMC & Device team, you will work closely with teams across Global Regulatory Affairs, Product  Supply, Quality, and external partners. This highly collaborative environment offers the opportunity to drive innovation and make a lasting impact within regulatory affairs.

Contact and Application

If this exciting opportunity aligns with your expertise, we’d love to hear from you!

You do not need to upload a cover letter, but feel free to include a few sentences in your CV about why this position excites you. Please refrain from adding a photo to your CV.

Beyond the Skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to positively impact patients, colleagues, and the planet. We empower individuals to drive change and create visible impact in a dynamic and supportive environment.

Diversity is at the heart of our success. We welcome candidates from all backgrounds to join our passionate team as we work together to make a difference.

Apply now to start shaping the future at LEO Pharma!

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