Pharmazac is one of the fastest growing pharmaceutical developers in Greece and operates a fully equipped GMP certified R&D Laboratory. We are seeking to recruit an expert for our Regulatory Affairs Department.
Regulatory Affairs Officer
This position, reporting to the Regulatory Affairs Manager ensures appropriate licency and legal compliance of a range of Pharmaceutical products in order to control their safety and efficacy.
Position’s responsibilities include:
Preparation and compilation of Module 1 (administrative part of the dossier) in alignment with the current local and EU legislation. Be able to handle the process of Registration of Medicinal products in Greece and International Territories.
Be able to run DCP and MRP applications in line with assigned timelines.
Liaise closely with the local and European Regulatory Authorities in order to ensure that any issue (deficiency letter) is identified and resolved in time.
Handle Variations, Renewals of company’s Pharmaceutical Licences and be responsible for the Transfer of Ownerships (MAH transfers).
Assist on the Tech Transfer processes.
Be responsible of the National Translations of the Product Information (SmPC, PIL and Labeling) in accordance with current guidelines. Preparation and Reviewing of Mock-ups (Artworks).
Knowledge and use of RA tools (Use of eCTD will be considered an asset).
Candidates for this position should fulfil the following qualifications:
Life Science Bachelor Degree (Biology, Chemistry or related scientific discipline)
At least 3 years of previous work experience in a Regulatory Affairs Department
Excellent verbal and written communication skills in English language.
Team working spirit and communication skills are a plus.
PHARMAZAC offers competitive remuneration package and benefits, according to the candidate,and provides the opportunity to join a fast growing team within a vibrant culture.