Regulatory Affairs Manager New

3 weeks ago

Nenagh, County Tipperary, Ireland CPL Full time
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

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