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Regulatory Affairs Director

1 week ago


Nenagh, County Tipperary, Ireland Cpl Healthcare Full time

**Role Overview**

Cpl Healthcare is seeking an experienced Regulatory Affairs Manager to join our team as a Regulatory Affairs Director. This role offers the opportunity to lead regulatory activities, manage submissions, and develop global regulatory strategies for key projects.

About the Role

  • Lead regulatory strategy for key projects, ensuring compliance with global requirements.
  • Manage regulatory submissions, including new registrations, post-approval changes, renewals, and technical variations.
  • Track regulatory commitments, assess risks, and provide strategic input on development plans.
  • Act as a scientific and technical resource, mentoring colleagues and sharing expertise.
  • Prepare responses to regulatory authority queries, ensuring timely and high-quality submissions.
  • Stay updated on evolving regulations and assess their impact on existing and future products.
  • Collaborate with internal stakeholders across R&D, Manufacturing, and Regulatory Affairs.
  • Engage with regulatory authorities (HPRA and other EU bodies) to support marketing authorisation applications.
  • Review GMP documents such as change controls, deviations, and batch manufacturing records.
  • Represent the company at industry conferences and regulatory advisory committees.

What We're Looking For

We require a minimum of 5+ years of experience in Regulatory Affairs within the pharmaceutical industry. A strong understanding of EU and global regulatory frameworks, including HPRA submissions, is essential. The ideal candidate will have excellent project management, communication, and stakeholder engagement skills.

Why Cpl Healthcare?

  • Work with a global pharma leader in an impactful regulatory role.
  • Collaborative environment with strong career development opportunities.
  • Exposure to international markets and regulatory bodies.