Regulatory Affairs Manager
The Macure Group is growing, and we are now looking for a new Regulatory Affairs Manager to join our Regulatory Team in Copenhagen.
You will become part of a highly skilled RA team that values collaboration, knowledge sharing, and the opportunity to influence. At Macure, you will experience task diversity and real impact—something only a young growth company can offer.
The Role
You will report to the Head of Regulatory Affairs, and your responsibilities will be spanning the full RA life cycle for our portfolio of products and Marketing Authorisations across Europe. And you will work closely with colleagues in our offices in Copenhagen, Malta, UK and beyond.
Your responsibilities will include:
- Managing regulatory projects across the RA life cycle
- Developing regulatory strategies for pipeline products
- Working closely with our Business Development team on the development of future products
- Submitting and handling National, MRP, and DCP procedures (mainly in Europe)
- Lifecycle management of your own portfolio of products
- Coordinating activities with CMOs, external partners, and health authorities
- Contributing to process improvements and SOPs within RA
Your Profile
We are looking for someone who thrives in a dynamic environment, enjoys variety, and proactively seeks ways to enhance results and processes.
Ideally, you bring:
- A Master’s Degree in Life Science (M.Sc. Pharmacy or equivalent)
- Solid experience in international pharmaceutical Regulatory Affairs
- A positive, business-oriented mindset and strong communication skills
- The ability to own, lead, and deliver projects under deadlines
- Fluency in English and preferably a Scandinavian language
- Hands-on experience with submissions (eCTD compiling/publishing) is considered a strong plus
Why Join Macure?
At Macure Pharma, you will experience:
- Significant responsibility and influence on your work and projects
- A dynamic, informal, and international work environment
- A strong team spirit and a culture where we celebrate success
- The freedom to balance flexibility at work with a meaningful life outside
Application
For more information, feel free to contact Head of HR, Anne Grue Larsen +45 6022 1716
We review applications continuously, so please submit yours in English as soon as possible to job@macurepharma.com.
