Regulatory Affairs Specialist

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 team at Ferring Pharmaceuticals. As a key member of our Small Molecule team, you will be responsible for ensuring the regulatory compliance of our products and development projects.

Key Responsibilities
  • Develop and implement regulatory strategies for CMC activities, ensuring compliance with global regulations and guidelines.
  • Collaborate with cross-functional teams, including manufacturing sites, QA, and supply organization, to ensure seamless execution of regulatory submissions and approvals.
  • Provide regulatory expertise and guidance to project teams, ensuring that CMC changes are assessed and documented in a timely manner.
  • Drive and execute scientific advice with national competent authorities, ensuring that CMC activities are aligned with regulatory requirements.
  • Participate in the development and optimization of departmental and working processes, ensuring efficiency and effectiveness.
Requirements
  • Minimum 5 years of experience in global regulatory affairs, preferably in CMC activities.
  • M.Sc. in a life science or pharmacy.
  • Excellent communication and negotiation skills, with the ability to deal with ambiguity.
  • Proven ability to work in a team environment, with a strong focus on collaboration and stakeholder management.
  • Experience with IT systems, 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 market innovative therapies that address unmet medical needs. We are committed to empowering our employees to achieve excellence and supporting their career development.

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