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Regulatory Affairs Manager
2 weeks ago
We are seeking a Regulatory Affairs Manager to join our team in Carlow. As a key member of the IPT, you will be responsible for ensuring compliance with regulatory standards while supporting manufacturing operations.
About the RoleThis shift-based role requires real-time quality oversight and adherence to cGMP and regulatory requirements. Your primary responsibilities will include reviewing and approving manufacturing batch documentation, providing on-the-floor support, and collaborating with Quality Specialists and QA Leads.
- Ensure compliance with US & European cGMP guidelines and regulatory requirements
- Collaborate with Quality Specialists and QA Leads to resolve queries and drive compliance initiatives
- Support the training of teams on Quality Management Systems and regulatory compliance
We offer a competitive salary and benefits package, career progression opportunities, and a collaborative work environment. Our team is committed to delivering high-quality drug products, and we are looking for a skilled Regulatory Affairs Manager to join us.
