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Regulatory Affairs Officer (Hybrid)

Malta

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

Job Reference: YH289

  • Primary job focus
    Quality Assurance
  • Job type
    Full Time
  • Employment level
    Intermediate (1-3 years)
  • Employer industry
    Pharmaceuticals
  • Languages
    English
  • Job Reference
    YH289
  • Closing Date
    30/06/2023
  • Date Published
    05/05/2023
  • Status
    Evaluating CVs

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