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).

The company invites applications from career oriented Regulatory Affairs Professionals. We will employee candidates on the positions of Senior Specialists or Specialists based on the level of experience. 

Duties:  

• To prepare CTD as well as eCTD format dossiers for new products and update the ones for the existing products in compliance with the global regulations in force.
• To submit Marketing Authorisation Applications (MAAs) for both European Registration Procedures (DCP/MRP) and non-EU national procedures according to the commercial strategy of Medochemie Ltd, considering the different country specific requirements.
• To timely submit the necessary lifecycle regulatory activities (renewals and variations) in all territories as necessary so that all Marketing Authorisations are up to date.

Qualifications: 

• University degree in a relevant science (Pharmacy, Chemistry, Biochemistry, Biology, etc). A post graduate degree will be considered an asset.
• At least 3 years of experience within the pharmaceutical industry in the field of generic regulatory affairs.
• Solid knowledge of PhEur, 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.

Location: Limassol, CYPRUS  

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 apply online through our web site.     

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.