Job Description

Job Description Company Introduction Our client operates in the distribution of healthcare and pharmaceutical products. Job Responsibilities and Duties Prepare and submit regulatory documentation in a timely manner to maintain product registrations, including initial applications, variations, renewals, responses, PSURs/PBRERs, and labelling notifications; Ensure continuous compliance with applicable regulatory requirements and remain up to date with EU Directives and other relevant legislation; Maintain accurate and well-organised regulatory records, correspondence, and electronic databases to ensure accessibility and traceability; Liaise closely with the Regulatory Manager and regulatory counterparts overseas to ensure alignment on compliance matters; Maintain professional communication with the Medicines Authority, including attending meetings when required; Prepare regulatory reports and updates as requested by management; Perform artwork checks on incoming stock prior to release to ensure consistency with registered product details; Create and review labelling materials for products requiring over-labelling or repackaging; Attend local seminars and training sessions, including overseas training where necessary; Assist in the preparation and signing of tender documentation; Support internal self-inspections and compliance reviews; Conduct annual checks of supplier warehouses used for product delivery; Review transport temperature records prior to product release; Prepare psychotropic drug orders for pharmacies and wholesalers; Assist in the transfer of stock from quarantine to saleable status; Support the approval of returned goods for re-entry into saleable stock. Experience In possession of a Pharmacy Degree or equivalent qualification; Strong understanding of pharmaceutical regulatory frameworks and compliance requirements; Familiarity with EU regulatory procedures and product lifecycle management will be considered an asset. Personal Skills Fluent in English, both written and spoken; Strong written communication and documentation skills; Computer literate with good organisational abilities; Detail-oriented and methodical in approach; Ability to work independently while contributing effectively within a team environment. BroadWing

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