Global Regulatory Affairs Lead

Ferring Pharmaceuticals

Kastrup, Denmark

In your 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. In the Therapeutic Area Teams, we have the overall responsibility for developing and executing the global regulatory strategies, including worldwide submission planning, market expansions and label expansions.

Your day at Ferring

Reporting to the Senior Director in the Therapeutic Area team, you will be assigned to one or more projects or marketed products, and your responsibilities may encompass the following:

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.

Behind our innovation…There’s you

University degree in science (life science, health or medical sciences)
+ 8years 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

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