Global Pediatric Regulatory Affairs Leader

2 weeks ago

Dublin, Dublin City, Ireland beBeeLeadership Full time €124,000 - €170,000
Job Overview

This position offers a unique opportunity to lead the development of global pediatric regulatory strategies and oversee the execution of regulatory plans and objectives for pediatric products across various therapeutic areas.

As a senior regulatory representative, you will provide leadership and mentorship to direct reports, guiding them in the development and execution of regulatory strategies, plans, and objectives.

The successful candidate will have extensive experience in Global Regulatory Affairs, with a strong background in developing global pediatric regulatory strategies and leading cross-functional teams.

Key Responsibilities
  • Develop and execute global pediatric regulatory strategies, plans, and objectives for products across various therapeutic areas.
  • Provide leadership and mentorship to direct reports, guiding them in the development and execution of regulatory strategies.
  • Oversee the execution of regulatory plans and objectives, ensuring timely completion and compliance with established practices and policies.
  • Represent Gilead in negotiations with regulatory authorities as needed.
  • Identify and mitigate regulatory or pediatric-related risks, ensuring the development of effective mitigation and contingency plans.
Requirements
  • MA/MS/MBA/PhD with 12+ years' relevant experience in Global Regulatory Affairs.
  • Extensive experience in developing global pediatric regulatory strategies and leading cross-functional teams.
  • Strong leadership and mentorship skills, with the ability to guide and advise direct reports.
  • Exceptional interpersonal and negotiation skills, with the ability to communicate effectively with varying organizational levels.
  • Ability to summarize complex matters into a clear business case and roadmap for execution.
What We Offer

This role offers a competitive salary and benefits package, as well as opportunities for professional growth and development. As a member of our team, you will have the chance to work on exciting projects and contribute to the success of our company.

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