Title:Quality & Regulatory Affairs ManagerLocation:Clonmel, Co. TipperaryRole Type:PermanentWe are currently recruiting a Quality & Regulatory Affairs Manager to oversee the integrated Quality, Regulatory, Medical, and Scientific Affairs functions at a Pharmaceutical Company based in Clonmel, Co. Tipperary. The responsibility of the Quality and Regulatory Affairs Manager is to ensure seamless coordination across these critical domains. This role is responsible for all aspects of quality systems, regulatory compliance, and scientific/medical affairs, supporting both Generics and Consumer Healthcare products.Key ResponsibilitiesDepartment Leadership: Lead the Quality, Regulatory, Medical, and Scientific Affairs Department, managing all personnel and systems to ensure compliance with global standards.Regulatory Affairs: Oversee regulatory requirements for new and existing products, including drafting and coordinating documentation for new registrations, product maintenance (renewals and variations), and clinical trial dossiers. Ensure compliance with chemical-pharmaceutical quality standards globally, manage projects, coordinate responses to agency requirements, and monitor regulatory activities.Quality Management: Develop and maintain the Quality Management (QM) system, qualify suppliers, and manage deviation and change processes to ensure stable operations. Support equipment qualification and validation of new processes.Medical & Scientific Affairs: Collaborate closely with Medical and Scientific Affairs to ensure coherent coordination on all quality, regulatory, and scientific queries. Facilitate the integration of scientific and medical insights into regulatory and quality strategies.Stakeholder Engagement: Act as the primary liaison internally with Marketing, Operations, Supply Chain, and other internal departments to ensure effective communication and collaboration. Also lead the key engagement and cooperation with external key stakeholders such as STADA Global and Regulatory Authorities HPRA and FSAIAudit & Compliance: Lead and participate in supplier, internal, and customer audits, as well as regulatory inspections (e.g., HPRA). Oversee the Qualified Person (QP) in the release of products, ensuring the highest quality standards are met.Qualifications & RequirementsBachelor's or Master's degree in Quality, Biotechnology, Pharmacy, Chemistry, Biology, or a related scientific field (ideally with a master's or doctorate).In-depth knowledge and experience in regulatory, quality, medical, or scientific affairs.Initial knowledge of quality management systems (ISO 9001, ISO 13485, HACCP, IFS, FDA).Demonstrated ability to manage cross-functional teams and projects in a regulated environment.