Regulatory Affairs Specialist (Hybrid)

Our client is looking for a Regulatory Affairs Specialist working in the pharmaceutical industry who 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 authorization applications and post-approval variations, to regulatory agencies. Your responsibilities would include:   

• Receiving training and implementing 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. 

Job Requirements  

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

The salary package will be determined according to the candidate's profile and experience