Regulatory Affairs Manager

4 weeks ago

Cork, Cork, Ireland Cpl Full time
Regulatory Affairs Manager – Pharma

Location: Cashel

Employment type: Permanent | Full-Time

About The Role

We are seeking an experienced Regulatory Affairs Manager to join a global pharmaceutical leader. This role offers the opportunity to lead regulatory activities, manage submissions, and develop global regulatory strategies.

What You'll Do
  • 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 You Need
  • Experience: Minimum 5+ years in Regulatory Affairs within the pharmaceutical industry.
  • Knowledge: Strong understanding of EU and global regulatory frameworks, including HPRA submissions.
  • Skills: Excellent project management, communication, and stakeholder engagement.
  • Education: Degree in Life Sciences, Pharmacy, or a related discipline.
  • Advantageous: Experience in CMC, post-market surveillance, and regulatory strategy development.
Why Join Us?
  • Competitive salary + Annual Incentive Plan
  • 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
Seniority level
  • Mid-Senior level
Job function
  • Legal
Industries
  • Staffing and Recruiting

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