Regulatory Affairs Specialist

5 months ago


Malta Konnekt Full time

Our client is searching for a professional Regulatory Affairs Specialist in the pharmaceutical field. This role involves ensuring that the company's products meet all regulatory standards. Responsibilities for this position include:

  • Receiving training and implementing regulatory SOPs for the local MAH entity
  • Contributing to updates needed for technical agreements
  • Maintaining the regulatory system in line with product Marketing Authorisation
  • Performing regulatory functions for Marketing Authorization holder for company MAs
  • Managing regulatory dossiers and national phase filings for Malta
  • Collaborating with MMA for DCP appointments and re-starts
  • Updating regulatory software and XEVMPD
  • Contributing to the enhancement of Quality systems and procedures
  • Representing the company in regulatory activities during MMA inspections

Job Requirements:

  • Bachelor's or Master's degree in RA or Pharmaceutical Sciences
  • Minimum of 2 years of experience in a relevant pharma position
  • In-depth knowledge of regulatory requirements for pharmaceutical products
  • Excellent communication and problem-solving abilities
  • Proficiency in both verbal and written English, with knowledge of Maltese as a plus

The salary will be based on the candidate's qualifications and background.