Product Lifecycle Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full time

Oresund Pharma ApS is seeking a Product Lifecycle Specialist to join our Regulatory department. In this role, you will be responsible for ensuring compliance with regulatory requirements and commercial demands worldwide.

As a key member of our team, you will focus on juggling and structuring various tasks, collaborating with both internal and external stakeholders to contribute to a good and open working environment.

You will play a fundamental role in helping shape processes and procedures to achieve timely and best practice regulatory life cycle management.

Responsibilities
  • Ensure compliance with regulatory requirements and commercial demands worldwide.
  • Prepare, review, and compile regulatory submissions.
  • Create product information (SmPC, labeling, and patient leaflets).
  • Monitor and set timelines for product maintenance, variations, and renewal approvals.


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