Pediatric Regulatory Affairs Leader

1 week ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €145,000 - €185,000

We are creating a healthier world by developing therapies that improve lives and ensure access globally.

Our team plays a critical role in discovering and developing life-changing scientific innovations. Every member is our greatest asset as we work to achieve our bold ambitions, seeking passionate individuals ready to make a direct impact.

We believe every employee deserves great leadership. People Leaders act as key drivers in evolving our culture, creating an inclusive environment where employees feel developed and empowered to fulfill their aspirations.

Job Role

This role is a core function within Global Regulatory Affairs, acting as a strategic partner across drug discovery, development and commercial teams.

As a Senior Director of Pediatric Center of Excellence, you will be a senior regulatory representative and pediatric subject matter expert to cross-functional leaders and teams.

You will oversee and guide the development and execution of regulatory strategies for pediatric development of products across various therapeutic areas, in alignment with global development objectives.

This may include preparing regulatory submissions, monitoring progress and completion of commitments, and guiding colleagues in completing activities.

Key Responsibilities:
  1. Oversight of pediatric regulatory strategies, submissions and deliverables for products across various therapeutic areas.
  2. Contribution to ongoing development and optimization of pediatric regulatory strategies, processes and practices.
  3. Representation in negotiations with regulatory authorities as needed.
  4. Identification of regulatory or pediatric-related risks/issues and timely development of mitigation plans.
  5. Management of one or more direct reports.
Requirements:
  • Masters/PhD with 12+ years' relevant experience.
  • Extensive experience in Global Regulatory Affairs and developing global pediatric regulatory strategies.
  • Experience working with multiple therapeutic areas and stages of drug development.
  • Leadership experience and effectiveness through direct people leadership or matrix leadership.
  • Proven track record of managing complex projects and leading cross-functional teams.

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