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Global Regulatory Lead

2 months ago

Kastrup, Denmark Ferring Pharmaceuticals, Inc. Full time
About the Role

We are seeking a highly experienced Global Regulatory Lead to join our Therapeutic Area team at Ferring Pharmaceuticals, Inc. This is a challenging position that requires a strong regulatory background and expertise in driving the development of global health care solutions.

Key Responsibilities
  • Represent the Global Regulatory Affairs function in the Global Project Team and chair the Global Regulatory Teams to provide regulatory strategic expert input to drive project/product progression.
  • Develop 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, and liaise with health authorities and experts to obtain scientific advice to mitigate regulatory risks and enable project progression.
  • 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.
  • 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, and 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, and provide regulatory input to evaluation of external business opportunities (due diligence).
  • Contribute to the continuous improvement of the department and GRA working processes.
Requirements
  • 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 judgment, 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.
About Ferring Pharmaceuticals, Inc.

Ferring Pharmaceuticals, Inc. is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. We focus our R&D efforts on peptide-based drugs and biotechnology-derived medicines. Our company is committed to advancing innovative therapies for the treatment of diseases within the Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas.

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.