Ref No: AGS037

The Company

Alfred Gera & Sons Ltd. is one of the leading distributors in Malta specialising in the distribution of pharmaceuticals and personal care products. Committed towards excellence, we represent global and prestigious household names and offer specialised healthcare related services. 

We take great pride in our reputation as a company of integrity, fostering an environment where our team members can grow and build fulfilling careers.

We are seeking a Regulatory Officer to join our Regulatory Affairs Team.

Key Responsibilities:

• The regulatory officer shall submit in a timely manner any documentation (e.g. initial application, variations, renewals, responses, PSURs/PBRER, labelling notifications) required to maintain the registration of the product.
• The regulatory officer shall work diligently with good management and organisational skills.
• The regulatory officer shall be required to keep up to date on all regulatory matters including EU Directives.
• All documents, records and correspondence shall be neatly filed in an orderly manner so that they are easily accessible including electronic databases.
• The regulatory officer shall be required to attend local seminars and if necessary accept training overseas.
• The regulatory officer shall liaise closely with the Responsible Person and the regulatory counterparts overseas.
• The regulatory officer shall have excellent relations with the Medicines Authority and when necessary have meetings with them.
• When required the regulatory officer shall be requested to submit reports on regulatory matters.
• The regulatory officer shall perform artwork checks of stock received before release against registered details.
• The regulatory officer shall be responsible to create/check any labelling material required for over labelling of products via repackaging.
• The regulatory officer shall assist the Responsible Person in any of the following duties:
  • Assist in the compilation and signing of tenders.
  • Assist in self inspections.
  • Perform yearly checks to verify suppliers’ warehouses used for delivery of AGSL goods.
  • Assist with the review of transport temperature records of products for their release.
  • Prepare psychotropic drug orders for pharmacies and wholesalers (in case regulatory officer is a registered pharmacist).
  • Assist in transfer of stock from quarantine to saleable on behalf of RP.
  • Assist in approving any returns to saleable stock.

Key Qualifications:

• Minimum qualification and education:
  • Pharmacy Degree or equivalent.
• Other competencies:
  • Well spoken in Maltese and English.
  • Good writing skills.
  • Computer literacy.
  • Organized.
  • A good team player.

Previous experience in a similar role is an advantage.

How to Apply

Apply with the form below or submit your application letter and a detailed CV to recruitment@alfredgera.com.

All applications will be acknowledged and treated in strictest confidence. Any soliciting will automatically disqualify the applicant. 

All data received is subject to the Data Protection Act.