Global Regulatory Affairs Manager

Global Regulatory Affairs Manager

Ferring Pharmaceuticals

Kastrup, Denmark

Your day at Ferring

As a Global Regulatory Affairs Manager, you will be responsible for CMC activities related to the life cycle management of products within our Biologics portfolio.

Depending on your experience, you will drive or support the following activities:

  • be responsible for the CMC aspect of regulatory submissions and approvals for worldwide market expansions and renewals;
  • provide regulatory CMC strategies and expertise to cross-functional teams such as global regulatory project teams, CMC teams, product teams, and launch teams;
  • represent Global Regulatory Affairs (GRA) in due diligence processes and provide GRA CMC input;
  • perform regulatory impact assessments of CMC changes for established products and drug substances – and ensure that adequate documentation is generated, submitted, and approved on time worldwide.

Behind our innovation – there’s you

If you see yourself in a team that values the social aspects of going to work while maintaining high professionalism, we would love to hear from you.

In addition to being social, you are well-organized, which means you can plan, execute, and meet deadlines, allowing you to act as a representative for GRA CMC in cross-functional project teams.

We imagine that you:

  • have a degree in life science or pharmacy;
  • have 3+ years of experience in global regulatory affairs (preferably CMC);
  • have experience with CMC documentation and global variation packages;
  • have excellent communication skills – verbal and written;
  • are a true team player who is excited to make a positive impact on your surroundings.

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