Regulatory Affairs Manager

Regulatory Affairs Manager – Pharma

📍 Location: Cashel

💼 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

If you’re a regulatory expert looking to take the next step in your career, apply now!

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