Regulatory Affairs Manager, International Pharma (CPH)

The Macure Group is growing, so we need another colleague for our Regulatory Team in Copenhagen. Join us and become part of our team of presently six highly skilled RA pharmacists. We guarantee great colleagues, influence that matters, personal development, and the unique opportunity of task diversity that comes with being part of a young growth company.

The Macure Group specializes in the international supply of niche hospital products. We currently experience a steep growth through acquisitions of established products and the launch of our own niche generics. We have a robust network of contract manufacturers and wholesalers/distributors, providing us with a flexible and scalable business structure.

You will report to our Head of Regulatory Affairs, and your responsibilities will span over the entire RA life cycle, encompassing activities across our three legal entities in Denmark, the UK, and Malta. The place of work is our headquarters in Copenhagen (NV).

THE JOB

Your responsibilities will include, but are not limited to:

  • Project management of regulatory projects
  • Submitting and managing National, MRP, and DCP procedures, primarily in Europe
  • Regulatory lifecycle management of your own portfolio
  • Developing regulatory strategies for pipeline products
  • Coordinating regulatory activities with external collaboration partners, CMOs, and authorities

YOUR PROFILE

It is essential that you excel in an environment characterized by variety and possess a proactive approach to continuously enhancing results and processes. Your profile ideally aligns with the following:

  • Master’s Degree in Life Science (M. Sc. Pharmacy or equivalent)
  • Experience in international Pharmaceutical Regulatory Affairs
  • Positive, open-minded, and business-orientated
  • Willing to own, lead, and deliver projects with a strong commitment to deadlines
  • Ability to thrive in a dynamic and agile organization, where flexibility is key for success
  • Excellent oral and written communication skills in English and at least one Scandinavian language.

MACURE PHARMA OFFERS

You will get a significant degree of individual responsibility and the freedom to structure your own day-to-day tasks in an international and fast paced atmosphere. Our work environment is very informal, we value a strong team spirit and are good at celebrating our successes.

APPLICATION

Feel free to contact HR Business Partner, Lotte Tolstrup at +45 40329734 for further information. Candidates are interviewed continuously; therefore, please submit your application in English as soon as possible to job@Macurepharma.com.