The companyClonmel Healthcare, the Irish affiliate of German multinational STADA Ag, is one of the largest suppliers of pharmaceutical product to the Irish market. Headquartered in Clonmel, the company has an extensive range of Prescription, OTC and Speciality Medicines. For 50 years we have stood for the highest levels of quality in supplying pharmaceutical products. Our purpose is caring for people's health as a trusted partner.Title of role: Regulatory Affairs SpecialistReporting to: Director of Quality/Regulatory AffairsQualifications: Third level qualification in science, pharmacy or related discipline essentialOne to two years experience in Regulatory, Quality or Pharmacovigilance affairs is desirable but not essential as full training will be providedDuties will include but not limited to:Maintenance of existing marketing authorisations including preparation of renewals and variationsPreparation of module 1 and 3 of Common Technical Document (CTD) in respect of Clonmel Healthcare registrationsReview of artwork, master production control records and change requestsPreparation of SmPCs, PILs and labelling for Clonmel productsLiaise with other departments and other companies to ensure regulatory compliance with Clonmel Healthcare Ltd marketing authorisationsApproval of AdvertisementsUpdating and adding SmPC's to the company website.Operator of the Denzapine Monitoring Service (DMS)Job Type: Full-timeWork Location: In person