Job Summary
We are seeking a highly experienced Regulatory Affairs Specialist to lead our Pediatric Center of Excellence in Dublin, Ireland. As a key member of our Global Regulatory Affairs team, you will be responsible for developing and executing regulatory strategies for pediatric development of products across various therapeutic areas.
About the Role
This is an exciting opportunity to join our dynamic team and contribute to the advancement of research and development of treatments for children with serious diseases. You will work closely with cross-functional leaders and regulatory authorities to determine appropriate pathways to obtain and maintain licensure and optimal formulary listings.
Responsibilities
* Oversight and leadership of global pediatric regulatory strategies, submissions, documents, activities, and other deliverables for products across the Virology, Oncology, and Inflammation Therapeutic Areas (TAs)
* Makes significant contributions to the ongoing development and optimization of pediatric regulatory strategies, processes, standards, and practices in collaboration with Global TA Regulatory Liaisons and cross-functional teams
* Represents the organization in negotiations with regulatory authorities as needed
* Proactively identifies regulatory or pediatric-related risks/issues and ensures timely development of mitigation and/or contingency plans
* Manages one or more direct reports
* Provides accurate and thorough input and recommendations into resource plans required to complete deliverables
* Tracks resources to ensure compliance with agreed resource allocation, including budgets
* Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements
* Provides significant leadership as a member of the Global TA Regulatory Liaison leadership team and leads or contributes to non-program-related corporate/department initiatives, process improvements, best practices, and projects
* Provides leadership and advisement for Pediatric Center of Excellence site management
Requirements
* MA/MS/MBA/PharmD/PhD with 12+ years' relevant experience; BA/BS with 14+ years' relevant experience
* Extensive experience in Global Regulatory Affairs (pharmaceutical industry experience strongly preferred) and developing global pediatric regulatory strategies
* Experience working with one or more Gilead therapeutic areas and varying stages of drug development (strongly preferred)
* Extensive leadership experience and proven effectiveness through direct people leadership or matrix leadership
* Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products
* Experience and proven effectiveness negotiating with regulatory authorities
* Extensive experience leading and influencing cross-functional teams and activities across a broad spectrum of programs, projects, and other activities
* Proven track record of successfully managing large-scale, complex, time-sensitive projects
Skills and Qualifications
* Exceptional interpersonal, self-awareness, and negotiation skills, including effective verbal/written communication, team orientation, critical thinking, active listening, problem-solving, dependability, and adaptability, and understanding of team dynamics
* Expert knowledge of the drug development process, and global and regional regulatory requirements for medicinal products
* Advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, and understanding and effectively advising on its regulatory implications
* Demonstrable ability to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees
* Ability to summarize complex matters into a clear business case and roadmap for execution
* Strong coaching capabilities to mentor/develop staff
* Ability to travel when needed
About Us
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at our organization. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed, and empowered to fulfill their aspirations.
Contact Information