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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