Global Regulatory Affairs Leader

11 hours ago


Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full time
Role Overview

Ferring Pharmaceuticals A/S seeks a seasoned Global Regulatory Affairs Manager to lead the lifecycle projects for one of our products in the Small Molecule team.

Responsibilities
  • Develop and execute regulatory strategies for worldwide market expansions and approvals, ensuring compliance with global regulatory requirements.
  • Collaborate with cross-functional teams, including manufacturing sites, QA, supply organization, project teams, and colleagues within global regulatory affairs, to drive CMC activities and achieve regulatory submissions and approvals.
  • Provide regulatory CMC expertise and guidance to teams, identifying and mitigating potential risks and ensuring adequate documentation is generated, submitted, and approved timely worldwide.
  • Drive scientific advice discussions with national competent authorities in relation to CMC activities, fostering open communication and cooperation.
  • Contribute to the development and optimization of departmental and working processes, promoting efficiency and excellence in regulatory affairs.
Requirements
  • +5 years of experience in global regulatory affairs, preferably within regulatory CMC activities.
  • M.Sc. in a life science or pharmacy.
  • Excellent communication and negotiation skills, with the ability to facilitate risk management discussions and collaborate with diverse stakeholders.
  • A proactive mindset, with a desire to find innovative solutions to regulatory challenges.
  • Strong organizational and time management skills, with the ability to plan, execute, and meet deadlines.
  • True team player with good negotiation skills and the ability to deal with ambiguity.
  • Experienced use of IT (including MS Office).
Company Overview

Ferring Pharmaceuticals A/S is a global biopharmaceutical company dedicated to helping people build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in reproductive and women's health, gastroenterology, and urology.

Benefits

At Ferring Pharmaceuticals A/S, we empower and support each other across the organization to achieve excellence together. We offer competitive compensation, comprehensive benefits, and opportunities for career growth and development.



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