Regulatory Affairs Specialist (Hybrid)

  South of Malta  |  €25,000 - €34,000  

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

Job Reference: UU280


  • Category
    Quality Assurance
  • Job type
    Full Time
  • Employment level
    Intermediate (1-3 years)
  • Work Location
    Hybrid
  • Employer industry
    Pharmaceuticals
  • Languages
    English
  • Job Reference
    UU280
  • Date Published
    17/04/2024
  • Status
    Interviewing

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