Product Regulatory Compliance Specialist

3 days ago


Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full time

We are looking for a skilled Regulatory Affairs Manager to lead our product regulatory compliance efforts at Oresund Pharma ApS.

This is a mid-senior level role that requires a deep understanding of regulatory requirements and processes. The ideal candidate will have a proven track record of managing complex regulatory projects, ensuring timely and cost-effective delivery.

Responsibilities include developing and implementing regulatory strategies, preparing regulatory submissions, and maintaining relationships with regulatory authorities.

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.

Requirements:
  • A strong scientific background, preferably an MSc in Pharmaceutical Science, Biology, Healthcare Sciences, or similar.
  • Minimum 5 years of experience working with regulatory activities, including Labelling, CMC, and/or other relevant aspects.
  • Proficiency in MS 365 and excellent analytical and problem-solving skills.


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