CMC Regulatory Expert

4 weeks ago


Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full time
About Ferring Pharmaceuticals

Ferring Pharmaceuticals A/S is a global company that helps people build families and live better lives. We are committed to scientific advances in reproductive and women's health, gastroenterology, and urology.

Job Title: CMC Regulatory Expert - Product Lifecycle

We are seeking an experienced Global Regulatory Affairs Manager to join our team as a CMC Regulatory Expert - Product Lifecycle. This role will be responsible for the lifecycle projects for one of our products.

About the Role

In this challenging position, you will work closely with stakeholders, project teams, and colleagues within global regulatory affairs to ensure timely worldwide market expansions and approvals. Your main responsibilities will include:

  • Regulatory CMC strategy and expertise to cross-functional teams.
  • Performing regulatory impact assessments of CMC changes.
  • Ensuring adequate documentation is generated, submitted, and approved timely worldwide.
About You

To succeed in this role, we believe your CV should comprise:

  • +5 years of experience in global regulatory affairs preferably within regulatory CMC activities.
  • M.Sc. in a life science or pharmacy.
  • Facilitation of risk management discussions is an asset.
About the Team

You will be part of our Small Molecule team who are responsible for the small molecules and peptides products. The department has robust expertise with small molecules, peptides, biologics, recombinant products, and is expanding to also excel in other modalities including gene therapy.

Benefits

As a Global Regulatory Affairs Manager at Ferring Pharmaceuticals A/S, you will enjoy:

  • A competitive salary range of approximately 85000-115000 DKK per annum.
  • A dynamic and entrepreneurial work environment.
  • Ongoing career development opportunities.


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