- Malta
- Job Search
- Konnekt
- Regulatory Affairs Specialist (Hybrid)
Job vacancy Regulatory Affairs Specialist (Hybrid)
Announced
18 April, 2024
Job Type
Full Time
Job Status
Employee
Job Title
Regulatory Affairs Specialist (Hybrid)
Job Location
South of Malta
Job Presentation
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
Reference number
UU280
Valid Till
18 Jul, 2024 (77 days left)
Share this job offer
JOB BY
Konnekt
Capital Business Centre, Entrance C, Level 2, Triq taz-Zwejt, San Gwann
View all 120 Jobs
+356 2123 4010
View all 120 Jobs
More Job Vacancies
Accounts Executive - Experienced- Edds&Co.Ltd.
Full Time | Employee | 1 May, 2024JOB BYPeople & Co. LtdAccounts Executive - Experienced- Edds&Co.Ltd.
Full Time | Employee | 30 Apr, 2024JOB BYPeople & Co. Ltd
See all jobs