Regulatory Affairs Manager – Pharma
We are seeking an experienced Regulatory Affairs Manager to join our team at a global pharmaceutical leader.
About the Role
This role offers the opportunity to lead regulatory activities, manage submissions, and develop global regulatory strategies that ensure compliance with international requirements.
Key Responsibilities
* Lead regulatory strategy for key projects, ensuring timely and compliant submissions.
* 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 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.
Requirements
* 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.