Director, Global Regulatory Affairs, Pediatrics

Gilead

Dublin, Ireland

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

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 and pediatric expertise are required
Broad experience in early to late stage of product development as well as post-approval phases
Strong leadership experience
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 global pediatric development in alignment with and within the overall development of a product.
Lead multiple projects for the pediatric indication across therapeutical 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 pediatric product development and global registrations
Work on extremely complex problems and provides solutions that have significant impact.
Ensure guidance on regulatory mechanisms to optimize pediatric 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, lead preparation of global pediatric plans, compile or review submission documents and correspondence with Health Authorities.
As needed, represents Gilead in negotiations with regulatory authorities. Oversees contacts for regulatory authorities. Lead preparation of documents, presentations and discussions in Health Autority meetings.
Attend key regulatory agency meetings which could impact the global product strategy
Be capable of managing complex negotiations with Regulatory Authorities to guide and support Regional Regulatory team.
Be capable of advising on a global pediatric strategy considering potential regional differences.
Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.
Effectively, proactively, and respectfully communicate and engage project teams to achieve regulatory goals and milestones.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
Work is performed under consultative direction of the Senior Global Regulatory Lead, Pediatrics, towards corporate regulatory goals and objectives.
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.
Schedules and arranges own activities.
Built trust to be recognized as a knowledgeable resource for Regulatory Advice in other departments.
Strong negotiation and conflict resolution skills.
Work in line with company core values