Regulatory Affairs Manager

5 dni temu


Warszawa, Mazovia, Polska TN Poland Pełny etat
Job Description:

We are seeking a highly skilled Regulatory Project Manager to join our team in Warsaw, Poland.

This is an excellent opportunity for a motivated individual to work with us and contribute to the success of our Classic & Established Products portfolio.

In this role, you will be responsible for ensuring compliance with regulatory requirements and guidelines while developing and executing regulatory strategies for assigned assets.

You will act as a Global Regulatory Lead, driving matrix team engagement and taking ownership of life cycle maintenance, including discontinuation of Marketing Authorizations (MAs).

The ideal candidate will have experience in all phases of the drug development process in regulatory affairs, with a focus on maintenance and lifecycle management of marketed products.

A degree in Biological or Healthcare Science is required, along with knowledge of European Regulatory landscape and procedural requirements.

Key Responsibilities:
  • Develop and execute regulatory strategies for assigned assets
  • Ensure compliance with regulatory requirements and guidelines
  • Act as a Global Regulatory Lead, driving matrix team engagement
  • Maintain accurate records and reports


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