Qualitis Ltd requires for immediate employment a Regulatory Affairs & Clinical Start-up Officer (Position Code: Q/RA-CSS/CL), who will be fully involved in the following:
a) Regulatory support of the pharmaceutical products of the Company’s Clients.
b) Clinical study start-up support of the Company’s studies portfolio
Our Company provides an excellent benefits package, including:
- Competitive Salary
- Private Health Insurance
- Annual Bonus
Job responsibilities mainly include:
CMC variation preparation, labeling variation preparation, proof reading of the labeling texts after Health Authority approval, new product registration preparation (MRP-DCP-National) including the preparation of all needed documents to be e-CTD ready for uploading to the virtual document.
- Clinical Study Start-up Support:
Development and follow-up of submissions and amendments to the relevant Authorities (Hospitals, EOF, National EC), maintenance activities throughout the lifecycle of the Study, management of the contract and budget processes in compliance with the appropriate guidelines and local regulations.
The ideal candidates should fulfill the following qualifications/requirements:
- Hold a University Degree, preferably in Health Sciences
- A minimum of two (2) years of experience in Regulatory Affairs position
- Experience in Study Start-up activities will be a strong asset, but not a prerequisite
- Excellent computer literacy with the MS Office Suite
- Ability to multitask and work in a fast-paced environment
Candidates should send their CVs in English indicating the position code, clicking on ``Apply``.