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 for our office in Athens, Greece.
University degree in a relevant science (Pharmacy, Chemistry, Biochemistry, Biology,). A post graduate degree will be considered an asset.
3-4 years’ experience within the pharmaceutical industry and preferably in the field of Regulatory Affairs.
Solid knowledge of Ph. Eur., EMA & ICH guidelines related to pharmaceutical product development and regulatory affairs and competency with e-CTD preparation.
Ability to work collaboratively in a team, and prioritize work in a dynamic and fast moving environment.
Very good interpersonal skills, analytical thinking and result orientation.
Fluency in both written and spoken English and computer literacy.
Ability to travel abroad.
To prepare CTD format dossiers for submission for generic pharmaceutical products in compliance with regulatory, and commercial strategy of Medochemie Ltd.
To successfully follow dossier submissions for both European Registration Procedures (DCP/MRP) and non-EU national procedures according the requirements
To successfully maintain dossiers’ and MAs’ lifecycle (variations & renewals) in all territories (EU & non-EU) where the products are registered.
Job Location: Athens, Greece
We are offering an attractive remuneration package and challenging opportunity for professional development.
Applicants should note that based on the General Data Protection Regulation (GDPR), all applications/CV’s 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.