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
1. Lead regulatory strategy for key projects, ensuring compliance with global requirements.
2. Manage regulatory submissions, including new registrations, post-approval changes, renewals, and technical variations.
3. Track regulatory commitments, assess risks, and provide strategic input on development plans.
4. Act as a scientific and technical resource, mentoring colleagues and sharing expertise.
5. Prepare responses to regulatory authority queries, ensuring timely and high-quality submissions.
6. Stay updated on evolving regulations and assess their impact on existing and future products.
7. Collaborate with internal stakeholders across R&D, Manufacturing, and Regulatory Affairs.
8. Engage with regulatory authorities (HPRA and other EU bodies) to support marketing authorisation applications.
9. Review GMP documents such as change controls, deviations, and batch manufacturing records.
10. 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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