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Regulatory Affairs Specialist

Job Description

Our client is  an international research-based pharmaceutical company.

Reports to: Regulatory Affairs Manager

-prepare translation and back-translation of the product information and prepare for submission

-prepare mock-ups for placing on the market after approval from Competent Authorities (CA)

-assure information of the product information to positions directly implied

-assure maintaining electronic and paper archive for authorization documents/documentation received from HQ/prepared locally during and after submission to the CA

-assure support for preparing the documentation for authorization/renewal/variations/other regulatory activities based on the documentation received from HQ/prepared locally

-ensure that company products comply with the national regulations

-ensure development of each allocated project within the dead-line established by the direct manager

-monitor and set timelines for approvals

-preliminary checking of documents and responsible for quality of documentation drafted for authorization/post-authorisation

-ensure compliance with the approved registration dossier

-ensure confidentiality of scientific data from the authorization documents and not disclose any confidential information to third party

-assure contact with CA for dossier submissions

-ensure support for any registration activity required by HQ, for example parallel trade, verifying readability user tests

Indicators for job description:

-experienced in regulatory affairs field for at least 3 years

-scientific background

-scientific and technical analysis

-analytical skills, detailed oriented person

-sense of responsibility

-good English written and spoken

-computer knowledge

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Irina Vasile
Tel & Fax: + 40 21 411 6114

Tel: + 4 031 437 09 75