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Regulatory Affairs Lead

3 weeks ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time
Regulatory Affairs Leader

We are seeking a highly skilled Regulatory Affairs professional to lead our global regulatory strategy. This is an exceptional opportunity to drive regulatory success and make a meaningful impact on the development and approval of new medicines.

The ideal candidate will have a deep understanding of global regulatory requirements, including FDA, EU, and ROW regulations. They will possess strong leadership skills, with the ability to develop and execute strategic plans, manage cross-functional teams, and communicate effectively with stakeholders.

Key responsibilities include:

  • Developing and implementing global regulatory strategies
  • Leading cross-functional teams to achieve regulatory milestones
  • Providing strategic advice and guidance to senior management
  • Ensuring compliance with global regulatory requirements

Required qualifications include a degree in a scientific discipline (MD, PhD, or PharmD) and 15+ years of experience in Regulatory Affairs. Proven success in regulatory submissions, including FDA and EU approvals, is essential.

We offer a dynamic and fast-paced work environment, with opportunities for growth and professional development. If you are a motivated and results-driven individual with a passion for regulatory affairs, we encourage you to apply.