Global Regulatory Manager

5 days ago


Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full time

Oresund Pharma ApS is a dynamic and ambitious company seeking a talented Global Regulatory Manager to join our Regulatory department.

In this role, you will be responsible for ensuring that our products comply with regulatory requirements and commercial demands worldwide. This includes managing regulatory submissions, establishing relationships with regulatory authorities, and driving process improvements.

The ideal candidate will have a strong scientific background, preferably an MSc in Pharmaceutical Science, Biology, Healthcare Sciences, or similar. Ideally, they will have a minimum of 5 years of experience working with regulatory activities, including Labelling, CMC, and/or other relevant aspects.

The successful candidate will be a strategic thinker with excellent communication and project management skills. They will also be able to navigate complex regulatory environments and drive process improvements.

Key Responsibilities:
  • Develop and implement global regulatory strategies.
  • Prepare, review, and compile regulatory submissions.
  • Maintain relationships with regulatory authorities worldwide.


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