Product Lifecycle Specialist
2 weeks ago
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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Application Lifecycle Specialist
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