Regulatory Affairs Specialist – Veterinary Medicines

 Regulatory Affairs Specialist – Veterinary Medicines  Location: [Dublin, Ireland or Remote (Global)]  Full-time | Department: Regulatory Affairs / Quality AssuranceAbout the RoleWe are seeking a proactive and detail-oriented Regulatory Affairs Specialist to join our team and support the development and registration of generic veterinary medicinal products for the EU market as well as support of our QA. This role is key in compiling and maintaining regulatory dossiers, ensuring GMP compliance, and contributing to the overall quality assurance framework.Key ResponsibilitiesLead or support the preparation, submission, and maintenance of EU regulatory dossiers for veterinary generics (MRP/DCP/National procedures), including activities related to the development of generic products.Provide regulatory input throughout the product development lifecycle, from R&D to registration.Ensure compliance with EU veterinary regulatory requirements and EMA/CVMP guidelines.Manage regulatory documentation and communications with Competent Authorities.Participate in and support CAPA investigations, change control, complaints, deviations, and root cause analysis.Contribute to the implementation and maintenance of Quality Management Systems in line with GMP/VMP regulations.Support internal and external audits and regulatory inspections.Liaise with cross-functional teams including QA, R&D, manufacturing, and pharmacovigilance.RequirementsDegree in Pharmacy, Veterinary Medicine, Life Sciences, or related field.Strong knowledge of EU regulatory procedures for veterinary medicines (especially generics).Familiarity with GMP guidelines, and QA processes.Experience with CAPA, change control, deviations, and complaints handling.Strong attention to detail, project management skills, and ability to work independently.Excellent communication skills in English (written and verbal).Nice to HaveMinimum 2 years of experience in Regulatory Affairs, Quality Assurance or QP release Experience with global markets Experience with pharmacovigilance or product lifecycle maintenance.Previous interaction with regulatory authorities (EMA or national agencies).  How to Apply Please submit your CV via LinkedIn