Regulatory Affairs Assistant - ANTAEA Medical Services - Athens

JOB ROLE:
The ideal candidate will be required to prepare and submit applications for approval of clinical trials, new licenses and variations to existing licenses, set up and maintain a complete, accurate and consistent database entry of records reflecting submission activity and keep up to date with changes in product licenses and ensure that variations and renewals are submitted on time.

PRINCIPAL RESPONSIBILITIES:
Preparing, Compiling, reviewing, and processing regulatory submissions, supplements, annual reports, field alert reports, study protocols and study reports. Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation. Ensure consistency, completeness, and adherence to standards for all regulatory submissions. Participate in the project/regulatory submission team and provide clear and consistent regulatory recommendations under an appropriate supervision Keep supervisor informed of all key regulatory issues. Ensure maintenance of regulatory document archive.

PRINCIPAL REQUIREMENTS:
Ideally you will be a graduate with a degree in Chemistry or Pharmacy or have 6-12 months Regulatory experience. In addition, excellent interpersonal skills with strong organizational skills with attention to detail is needed. Must be computer literate with proficient in MS office. Willing to travel depending on project needs. Very good knowledge of English language.

BENEFITS:
An outstanding opportunity to work for a growing company with a culture that fosters individual achievements and teamwork. If you want a challenging and rewarding career this company will provide what you need. They are offering a competitive salary according to experience together with a package that includes group life insurance, mobile phone and professional development etc.

Please email to Human.Resources@antaea.net or fax to +30 210 9485101
your updated CV (with a recent photo and a cover letter)
(Reference Code for this position: RAA0109)