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Senior Director Global Regulatory Affairs

3 months ago

England, UK, United Kingdom Life Science People Full time

Director, Global Regulatory Affairs

Ireland

Hybrid


This is an exciting opportunity to join a Global Regulatory Affairs team to develop and implement global regulatory strategic and leadership of regulatory activities for product development.


Specific Education & Experience Requirements:


  • Extensive experience in Global Regulatory Affairs (Pharmaceutical industry experience is strongly preferred)
  • Advance degree in a scientific field
  • Drug development experience required
  • Broad experience in early to late stage of product development as well as post-approval phases
  • Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.


Specific Job Responsibilities and required skills:


  • Responsible for providing strategic regulatory guidance on the development in alignment with and within the overall development of a product.
  • Lead multiple projects across therapeutic areas and define the regulatory strategy, plans and objectives for the assigned products or projects.
  • Accountable for developing a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development and global registrations
  • Work on extremely complex problems and provides solutions that have significant impact.
  • Ensure guidance on regulatory mechanisms to optimize product development (e.g. Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use, and pediatric plan) is assessed and incorporated into the global regulatory strategy
  • Must have hands-on knowledge of pediatric regulatory requirements, including ICH requirements and regional requirements for assigned territories and an understanding of current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business.
  • Experience with regulatory procedures and in developing required documentation for pediatric submissions in key regions with main focus on US and EU.
  • Must be able to work with one or more cross-functional core and sub-teams in preparation of submissions, compile or review submission documents and correspondence with Health Authorities.
  • Effectively, proactively, and respectfully communicate and engage project teams to achieve regulatory goals and milestones.
  • Must be able to work in multifunctional teams and be the regulatory voice for strategic project team decisions and in governance teams. Excellent teamwork is required.
  • Ability to manage multiple ongoing projects, each at various stages of development.
  • Excellent verbal, written, negotiation and interpersonal communication skills are required.