Our client, specialising in the distribution of pharmaceuticals and medical products, representing a broad portfolio of international brands and is recognised for its reliability, regulatory compliance, and efficient supply chain management is looking for a Regulatory Officer
The Main Responsibilities include:
- Prepare and submit regulatory documentation (applications, renewals, variations, PSURs/PBRERs, labelling notifications) in a timely manner.
- Maintain accurate records, databases, and correspondence, ensuring easy accessibility.
- Keep updated on EU Directives and regulatory requirements; prepare reports as needed.
- Liaise with the Medicines Authority, the Responsible Person, and overseas regulatory counterparts; attend meetings, seminars, and training (locally or abroad).
- Check artwork and labelling of products prior to release, including materials for over-labelling and repackaging.
- Support the Responsible Person with tenders, self-inspections, supplier warehouse audits, and temperature record reviews.
- Assist with psychotropic drug orders (if registered pharmacist), stock transfers from quarantine to saleable status, and approval of returned goods.
- Demonstrate strong organisational and time management skills in all tasks.
Working Hours:
8:00-16:30 or 8:30-17:00
Requirements
- Proficient in Computing Skills
- Organised
- Fluent in both Maltese & English
Education and Experience
- Degree in Pharmacy, Pharmaceuticals or a similar degree is a must
Job Reference: HY208
