Regulatory Affairs Officer (Hybrid)

Our client is looking for a Regulatory Affairs Officer working in the pharmaceutical industry is responsible for ensuring that a company's products comply with all relevant regulatory requirements. This includes coordinating the submission of regulatory documents, such as marketing authorisation applications and post-approval variations, to regulatory agencies. Your responsibilities would include: 

• Receiving training and implement as required, regulatory SOPs for the local MAH entity
• Contributing to updates required to technical agreements
• Upkeeping and maintenance of the regulatory system in accordance to the products’ Marketing Authorisation.
• Carrying out the regulatory functions of Marketing Authorization holder for MAs held by the company
• Managing regulatory dossiers 
• Managing national phase of filings done for Malta.
• Liaising with MMA for DCP appointments, DCP re-starts.
• Updating of regulatory software and XEVMPD.
• Contributing to the continuous development and improvement of Quality systems, processes and procedures.
• Participating and representing the company in regulatory activities when the company is inspected by MMA.
• Training of RA Officers.

Job Requirements

• A Bachelor's or Master's degree in Science
• 2 years experience in a relevant position
• Strong understanding of regulatory requirements for pharmaceutical products 
• Excellent communication and problem-solving skills
• Strong verbal and written English and preferably Maltese