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!
#LI-DB4
Jobs at CPL
Business Excellence Manager/Operations Manager