Regulatory Affairs Professional

2 months ago

Kastrup, Denmark Ferring Pharmaceuticals Full time
About the Role

We are seeking a highly experienced Regulatory Affairs Professional to join our Global Regulatory Affairs Therapeutic Area team at Ferring Pharmaceuticals. As a key member of our team, you will be responsible for driving the development of high-quality global regulatory strategies and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Represent the Global Regulatory Affairs team in the Global Project Team and chair the Global Regulatory Teams, providing regulatory strategic expert input to drive project/product progression.
  • Develop and execute global regulatory strategies, including worldwide submission planning, market expansions, and label expansions.
  • 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.
  • Provide regulatory input to evaluation of external business opportunities (due diligence).
  • Contribute to the continuous improvement of the department and GRA working processes.
About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a leading biopharmaceutical company dedicated to advancing innovative therapies for the treatment of diseases within the Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas. We strive to lead in innovation and adopt a global perspective, starting from the early stages of development.

What We Offer
  • A dynamic and inclusive work environment with a diverse team of professionals.
  • Opportunities for professional growth and development in a global company.
  • A comprehensive benefits package, including parental leave for both birthing and non-birthing parents, extended support on family building journey, and a global standard for equal and accessible policies for all employees who wish to start their family journey.
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.

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