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.