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Branded Generic Pharmaceutical Company is seeking for
PRODUCT DEVELOPMENT CMC OFFICER
(CMC/PD)
The CMC officer (Chemistry, Manufacturing and Controls) resides to the Product Development Department and her/his main responsibilities involve in brief the compilation of Mod.3 of the pharmaceutical product dossier of new developments as well as support, maintenance and upgrade of dossiers of completed developments.
Candidates should be up-to-date with relevant regulations and guidelines concerning quality/manufacturing of pharmaceutical products
Major responsibilities include, but are not limited to, the following:
Coordination, compilation and review of CTD of pharmaceutical and nutraceutical products
Support during dossier assessment by competent authorities following strict timelines
Communication and close collaboration with laboratory and manufacturing site of the company in order to collect the required data for compilation of the CTD dossier
Support the transfer of the procedures to production
Keep updated on regulations and guidelines published by competent authorities
The applicant should have:
Bachelor’s degree in Life Sciences (e.g Pharmacy and Chemistry)
Fluency in English both written and oral
Previous professional experience of at least 2 years in a pharmaceutical company in the field of regulatory affairs
Excellent computer literacy (MicroSoft Office)
Be multitasking
Cope with meeting deadlines
The Company offers high potential of development within a competitive European environment .