Regulatory Affairs Associate jobs in Pune - GxPpharmaceuticals Pvt Ltd

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Job Description

- Preparation and compilation of Module 2, 3, 4 and 5 for the regulated markets (Europe/Australia/Canada) in CTD/eCTD format.

- Handling queries on Quality, Clinical, Non-clinical and Bio-equivalence parts received from the different regulatory authorities.

- Submitting variation for the post approval changes for the regulated markets (Europe/Australia/Canada).

- Responsible for undertaking effective correspondence with QA, QC, Production and R&D department for the submission documents.

Industry

Medical/Healthcare

Functional Area

Pharma / R&D / Biotech

Number of Vacancy

1

Education

B.Pharma, B.Sc, M.Pharma, M.Sc


About GxPpharmaceuticals Pvt Ltd

GP is a multinational Australia based company engaged in Pharmaceutical Industry with affiliates in the UK & India

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