Regulatory Affairs Specialist
At Pharmacosmos, we are looking for a Regulatory Affairs Specialist who wants to help ensure that life-changing therapies reach patients worldwide by strengthening our global regulatory activities and ensuring regulatory compliance.
Your role
You will join our Regulatory Affairs team of 20 colleagues and work with marketing authorisations and lifecycle management of our products across international markets.
Your key responsibilities include:
Ensure effective global lifecycle management for marketed products, including maintenance activities for assigned products and markets
Lead and coordinate regulatory submissions for initial registrations in new global markets
Ensure regulatory compliance for assigned products through close collaboration with local partners and internal stakeholders
Prepare, review, and maintain regulatory documentation, including CMC documentation
Collaborate closely with cross-functional stakeholders, including QA/QC, R&D, Pharmacovigilance, Supply Chain and Commercial teams
Your profile
You have a relevant academic degree within life sciences (e.g. MSc, Pharmacy) and experience from similar position from the pharmaceutical industry.
The ideal candidate:
Bring at least 2 years of experience within Regulatory Affairs, preferably with lifecycle management and global regulatory activities; experience from the Chinese market will be considered an advantage
Is motivated by working with CMC documentation
Thrive in an international setting and is eager to contribute to global regulatory activities
Communicate fluently in both written and spoken English and Danish
As a person, you:
Thrive in a busy environment and enjoy being part of a collaborative team
Are curious and motivated to improve processes and ways of working
Work in a pragmatic way while maintaining a strong attention to detail where it matters most
Are structured, detail-oriented, and have a natural IT flair
What we offer
You will become part of an international and growing pharmaceutical company with a strong purpose: improving the lives of patients with unmet medical needs.
We offer a collaborative environment with skilled colleagues, opportunities for development, and a culture built on trust, accountability, and continuous improvement.
Application
If this sounds like the right opportunity for you, we look forward to receiving your CV and cover letter.
For questions about the position, please contact Director, Regulatory Affairs, Mads Dyrholm Jørgensen at +45 6166 4321.
Submit your CV and cover letter via the "Apply" button.
Application deadline: May 13, 2026.
About Pharmacosmos
Pharmacosmos A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anaemia. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood-related disorders. Founded in 1965 and headquartered in Denmark, our team is made up of more than 700 specialists across the UK, Ireland, the Nordics, Germany, Canada, and the USA.