Global Regulatory Expert

1 month ago

Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full time

Transformative Regulatory Leadership Opportunity

Ferring Pharmaceuticals A/S is dedicated to advancing innovative therapies for the treatment of diseases within the Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas. We are seeking an exceptional Global Regulatory Lead to join our Global Regulatory Affairs team in Copenhagen.

This is a challenging position that requires an experienced Regulatory Affairs Professional to drive the development of our current and next generations of healthcare solutions. As a Global Regulatory Lead, you will work in a team of highly skilled regulatory professionals responsible for the global regulatory activities for our development projects and marketed products.

Your Key Responsibilities

  • Represent GRA in the Global Project Team and chair the Global Regulatory Teams providing regulatory strategic expert input to drive project/product progression.
  • Drive the development of high-quality global regulatory strategies, including identifying regulatory opportunities and mitigation of risks, strategic submission and regulatory activity planning, and development of competitive labels in collaboration with relevant team members and stakeholders.
  • Plan and manage meetings with health authorities worldwide for the projects/products assigned. Drive and lead the preparation of high-quality briefing packages, liaising with health authorities and experts to obtain scientific advice to mitigate regulatory risks and enable project progression.
  • For late-stage projects, ensure submission and approvals of BLAs/MAAs in US, EU, Japan, China and other countries worldwide in collaboration with local regulatory colleagues, and drive the strategic planning of market expansions, including responses to authority inquiries.
  • For marketed products, prepare the regulatory LCM strategy and manage the strategic planning and execution of regulatory submissions and approvals for worldwide market expansions, renewals, and variations for the products assigned, leading the submission team and chairing the Labelling Management Team.
  • Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide input to clinical and nonclinical documentation and represent GRA in our Clinical Development, Safety Management teams, and/or Clinical Trial Team.
  • Represent GRA in project presentations and discussions with upper management and governance bodies at project milestones.
  • Provide regulatory input to evaluation of external business opportunities (due diligence).
  • Contribute to the continuous improvement of the department and GRA working processes.

About You

  • University degree in science (life science, 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.
  • Experience managing global regulatory activities and driving regulatory strategic project discussions, including preparing regulatory strategies and submissions.
  • 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.
  • Able to work in an international corporate environment with a diverse and fast-paced workday.
  • Fluency in English, excellent verbal and written communication skills.

Ferring Pharmaceuticals A/S

We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status. If you have any questions, you are welcome to contact the Talent Acquisition Sourcer, Patricia Martins. Note to agencies: this search is being managed by Ferring's Talent Acquisition team. Kindly do not send us spontaneous profiles.

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