The company
Clonmel 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 Specialist
Reporting to: Director of Quality/Regulatory Affairs
Qualifications: Third level qualification in science, pharmacy or related discipline essential
One to two years experience in Regulatory, Quality or Pharmacovigilance affairs is desirable but not essential as full training will be provided
Duties will include but not limited to:
* Maintenance of existing marketing authorisations including preparation of renewals and variations
* Preparation of module 1 and 3 of Common Technical Document (CTD) in respect of Clonmel Healthcare registrations
* Review of artwork, master production control records and change requests
* Preparation of SmPCs, PILs and labelling for Clonmel products
* Liaise with other departments and other companies to ensure regulatory compliance with Clonmel Healthcare Ltd marketing authorisations
* Approval of Advertisements
* Updating and adding SmPC's to the company website.
* Operator of the Denzapine Monitoring Service (DMS)
Job Type: Full-time
Work Location: In person