Regulatory Expert with Global Reach

1 week ago

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

Ferring Pharmaceuticals A/S is seeking an experienced Global Regulatory Lead to join our team in Copenhagen, Denmark. As a key member of our regulatory affairs department, you will play a critical role in driving the development and implementation of global regulatory strategies for our innovative healthcare solutions.

About the Role

  • You will be responsible for representing GRA in global project teams, chairing regulatory teams, and providing strategic input to drive project progression.
  • Develop high-quality global regulatory strategies, including identifying opportunities and mitigating risks, submission planning, and competitive labeling.
  • Plan and manage meetings with health authorities worldwide, preparing briefing packages, and liaising with experts to obtain scientific advice.
  • Ensure submission and approval of BLAs/MAAs in major markets, drive market expansions, and respond to authority inquiries.
  • Manage LCM strategy, execute regulatory submissions, and approvals for worldwide market expansions, renewals, and variations.
  • Compile, submit, and maintain CTAs and INDs for clinical trial-related activities, providing input to clinical and non-clinical documentation.
  • Represent GRA in project presentations, discussions with upper management, and governance bodies at project milestones.
  • Provide regulatory input to evaluation of external business opportunities.
  • Contribute to the continuous improvement of GRA working processes.

Your Background

  • University degree in science (life sciences, health, or medical sciences).
  • +8 years of comprehensive experience with drug development from phase 1 to launch, including health authority interactions (FDA, EMA, Japan, and China).
  • Experience with labelling, clinical trials, and other clinical and non-clinical regulatory activities.
  • Strong negotiation skills, solid judgment, and effective decision-making abilities.
  • Proactive, strategic, and team player with a positive mindset and constructive attitude towards driving results.
  • Able to work in an international corporate environment with a diverse and fast-paced workday.
  • Fluency in English, excellent verbal and written communication skills.

We Offer

  • An estimated salary range of €90,000 - €120,000 per annum, commensurate with experience.
  • A dynamic and inclusive work environment with a focus on innovation and collaboration.
  • The opportunity to work on cutting-edge projects that make a meaningful impact on people's lives.
  • A comprehensive benefits package, including parental leave, extended support for family building, and a global standard for equal access to fertility treatments.
  • A chance to contribute to a company that prioritizes diversity, equity, and inclusion, and strives to create a workplace where everyone feels valued and respected.

About Ferring Pharmaceuticals A/S

Ferring Pharmaceuticals A/S is a leader in reproductive medicine and maternal health, with a strong presence in gastroenterology and urology. Our Copenhagen office is home to nearly 600 scientists and specialists who are passionate about breaking new ground to help people live better lives. We focus our R&D efforts on peptide-based drugs and biotechnology-derived medicines, and we are committed to advancing innovative therapies that address unmet medical needs.

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