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
