Regulatory Affairs Specialist

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Holbæk

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 +[xxxxx].

Submit your CV and cover letter via the "Apply" button.

Application deadline: May 13, 2026.

About [xxxxx]
[xxxxx] 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 650 specialists across the UK, Ireland, the Nordics, Germany, Canada, and the USA.
Rapportér
  • 28.04.2026
  • Apoteker
  • Holbæk
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