Menarini Hellas, an international pharmaceutical company seeks to recruit a dynamic professional for the Regulatory Affairs Dpt.
The candidate will ensure the appropriate licensing of the company products and their maintenance to the Greek & Cypriot Regulatory Authorities.
The Main Responsibilities Include
- Access and reviews all scientific and technical evidences and responsible for the effective communication with the local Health Authorities for the Marketing Authorizations and registration notification of all products.
- Performs all necessary activities for the preparation and submission of applications for approval of variations/new Marketing Authorizations/Renewals to Greek and Cypriot authorities through national, mutual, decentralized and centralized procedures.
- Responsible for translation of regulatory documents (product information, variations applications, variation approvals, marketing authorizations) of all products of the company
- Responsible for the notification to health authorities (Cypriot & Greek) of non-pharmaceutical products.
- Maintains up-dated file in the company with the essential legal documents as well as the archives of the official correspondence regarding the department.
- Supports PV and Quality function.
- keeping up to date with changes in regulatory legislation and guidelines
Skills and Qualifications
- University Degree in Pharmacy, Medicine, Biology, Chemistry.
- Fluency in English / Fully computer literate.
- Minimum 2 years of experience in Pharma sector.
- Knowledge of regulations, legislation, policies and procedures related regulatory affairs procedures.
- Time management skills & Ability to work under pressure and to strict deadlines.
- Team player.
Remuneration
The company offers a competitive remuneration package and career prospects.
If you meet the above qualifications and believe that you can respond dynamically to the requirements of the position, please send us a curriculum vitae by entering the code position RA_2020 at hr@menarini.gr
All applications will be treated as confidential.
