Global Regulatory Affairs Manager

2 months ago

Kastrup, Denmark Ferring Pharmaceuticals Full time
About the Role

We are seeking a highly skilled Global Regulatory Affairs Manager to join our CMC department at Ferring Pharmaceuticals. As a key member of our team, you will be responsible for ensuring the regulatory compliance of our products and ensuring that our development projects meet the highest standards of quality and safety.

Key Responsibilities
  • Develop and implement regulatory strategies for CMC activities, ensuring compliance with global regulations and guidelines.
  • Provide regulatory expertise to cross-functional teams, including the Global Regulatory Project Teams, CMC Teams, Product Teams, and Launch Teams.
  • Perform regulatory impact assessments of CMC changes for development projects and established products, ensuring timely submission and approval worldwide.
  • Drive and execute scientific advice with national competent authorities in relation to CMC activities.
  • Participate actively in the development and optimization of departmental and working processes.
Requirements
  • Minimum 5 years of experience in global regulatory affairs, preferably in regulatory CMC activities.
  • M.Sc. in a life science or pharmacy.
  • Facilitation of risk management discussions is an asset.
  • A desire to find innovative solutions to regulatory challenges and a proactive mindset.
  • Well-organized and able to plan, execute, and meet deadlines.
  • True team player.
  • Good negotiation skills and the ability to deal with ambiguity.
  • Experienced use of IT, including MS Office.
About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a global biopharmaceutical company dedicated to helping people build families and live healthy lives. Our mission is to identify, develop, and bring to market innovative therapies that improve patients' lives. We are committed to empowering and supporting our employees in their career development and ensuring that all team members receive the right level of support and progression.

We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking for a new challenge, please apply with your CV and a few lines regarding your motivation for applying. We review applications on an ongoing basis and close the process when we find the right match.

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