Regulatory Officer

Job Description

Company Introduction

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.