REGULATORY AFFAIRS SPECIALIST – ATHENS
Medochemie Ltd is an International Pharmaceutical Company headquartered in Cyprus. Medochemie manufactures a wide range of products divided into more than 10 therapeutic categories, owns 4355 marketing authorizations and operates in more than 107 countries around the world. Our thirteen separate manufacturing sites are designed to fully comply with European and WHO current Good Manufacturing Practice (cGMP).
Medochemie Ltd invites applications from career oriented professionals for the position of Regulatory Affairs Specialist in our offices in Athens, GREECE.
The position:
- Be responsible for the CMC compilation of dossiers for new products and dossier updates for existing products, in eCTD format and in compliance with the global regulations in force.
- Submit Marketing Authorisation Applications (MAAs) and follow up till approval mainly for European Registration Procedures (DCP/MRP) according to the company’s strategy.
- Successfully maintain dossiers’ and MA’s lifecycle (variations & renewals) in all territories as necessary so that the MAs are up to date.
- Participate in developing Regulatory strategies within the department, interact and negotiate with competent Authorities and maintain close working relationship with internal stakeholders (e.g. QA, QC, production, commercial).
The candidate:
- University degree in a relevant science (Pharmacy, Chemistry, Biochemistry, Biology, etc). A post graduate degree will be considered an asset.
- 3 to 5 years experience in the pharmaceutical sector, in the field of generic product development and Regulatory Affairs.
- Knowledge and practical understanding of EU and non-EU pharmaceutical legislation, EMA & ICH relevant guidelines and competency with e-CTD preparation
- Ability to work collaboratively in a team, and prioritize work in a dynamic and fast changing environment.
- Strong communication, influencing and problem resolution skills.
- Ability to be adaptive to change, to multitask and give attention to detail.
- Very good interpersonal skills, analytical thinking and result orientation.
- Fluency in Greek and English (written and spoken) and computer literacy. Knowledge of any other languages will be considered an asset
- Ability to travel abroad if requested
Location: Athens, GREECE.
We are offering an attractive remuneration package and challenging opportunity for professional development.
If you wish to work in a pleasant, modern, professional environment with excellent career opportunities, please Submit your CV or Fill in the online Form through the website below:
http://www.medochemie.com/MainMenu/Careers.aspx
Applicants should note that based on the General Data Protection Regulation (GDPR), all applications/CV kept in our database have been deleted. In case you have forwarded us your CV in the past and you are interested in this position, please apply again.
All applications will be treated in strict confidence.
