Global Regulatory Affairs Expert

4 weeks ago

Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full time

Drive the development of innovative health care solutions at Ferring Pharmaceuticals A/S

We are seeking an experienced Regulatory Affairs Professional to join our Global Regulatory Affairs team. As a key member of our team, you will be responsible for driving the progression of our development projects and/or key marketed products within the Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas.

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. Our comprehensive approach encompasses a diverse range of treatment solutions. We strive to lead in innovation and adopt a global perspective, starting from the early stages of development.

In this role, you will work in a team of highly skilled regulatory professionals responsible for the global regulatory activities for our development projects and marketed products. You will be responsible for developing and executing the global regulatory strategies, including worldwide submission planning, market expansions and label expansions.

Your key responsibilities will include:

  • Representing GRA in the Global Project Team and chairing the Global Regulatory Teams providing regulatory strategic expert input to drive project/product progression.
  • Driving 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.
  • Planning and managing meetings with health authorities worldwide for the projects/products assigned. Driving and leading 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.
  • Ensuring submission and approvals of BLAs/MAAs in US, EU, Japan, China and other countries worldwide in collaboration with local regulatory colleagues, and driving the strategic planning of market expansions, including responses to authority inquiries.
  • Preparing the regulatory LCM strategy and managing 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.
  • Ensuring compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Providing input to clinical and nonclinical documentation and representing GRA in our Clinical Development, Safety Management teams, and/or Clinical Trial Team.
  • Representing GRA in project presentations and discussions with upper management and governance bodies at project milestones.
  • Providing regulatory input to evaluation of external business opportunities (due diligence).
  • Contributing to the continuous improvement of the department and GRA working processes.

What we offer:

Our new workplace will be our spectacular, state-of-the-art new domicile Soundport in Copenhagen, overlooking the ocean and close to the Airport and the Oresund bridge, with the option of working from home 2 days a week.

Candidates must be located in the Copenhagen region or willing to relocate at their own expense.

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 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.

At Ferring Pharmaceuticals A/S, we are committed to creating an inclusive and diverse workplace with equal opportunities and mutual respect for all employees.

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