Global Regulatory Lead

1 week ago

Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full time
Unlock Your Potential as a Global Regulatory Lead

Are you a seasoned Regulatory Affairs Professional looking to drive innovation and make a meaningful impact in the development of healthcare solutions? Do you have a passion for regulatory strategy and a knack for navigating complex global regulatory landscapes?

Ferring Pharmaceuticals A/S is seeking a highly skilled Global Regulatory Lead to join our team in Copenhagen. As a key member of our Global Regulatory Affairs team, you will play a critical role in shaping our regulatory strategies and ensuring compliance with global regulatory requirements.

Your Key Responsibilities:
  • Develop and implement global regulatory strategies for our development projects and marketed products
  • Represent GRA in global project teams and chair regulatory teams to drive project progression
  • Plan and manage meetings with health authorities worldwide and lead the preparation of high-quality briefing packages
  • Ensure submission and approval of BLAs/MAAs in key markets and drive strategic planning of market expansions
  • Prepare regulatory LCM strategies and manage submission teams for worldwide market expansions, renewals, and variations
  • Represent GRA in project presentations and discussions with upper management and governance bodies
  • Provide regulatory input to evaluation of external business opportunities and contribute to the continuous improvement of GRA working processes
Your Ideal Profile:
  • University degree in science (life science, health or medical sciences)
  • At least 8 years of comprehensive experience with drug development from phase 1 to launch, including health authority interactions
  • Experience with labelling, clinical trials, and other clinical and non-clinical regulatory activities
  • Strong negotiation skills, solid judgement, and effective decision-making abilities
  • Proactive, strategic, and team player with a positive mindset and a constructive attitude towards driving results
  • Fluency in English, excellent verbal and written communication skills
What We Offer:
  • A dynamic and inclusive work environment with a diverse team of experts
  • Opportunities for professional growth and development in a global company
  • A comprehensive benefits package, including parental leave and extended support for family building
  • A chance to make a meaningful impact in the lives of millions of people

Join us at Ferring Pharmaceuticals A/S and be part of a team that is shaping the future of healthcare. Apply now to take the first step towards an exciting career opportunity

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