Manager Regulatory Affairs API Position Vacant @ Cipla Ltd

Cipla Ltd
Cipla is one of the most respected pharmaceutical companies not just in India but across more than 170 countries. Our portfolio includes 2000 products in 65 therapeutic categories with one quality standard globally. Cipla’s turnover in FY13 was 1.5 billion USD.

Job Title  Manager Regulatory Affairs API

Job Description:

I.Contribute to the regulatory strategy by participating in the team discussion and providing regulatory input as per the current guidelines during the initial phase  of development till the submission of the dossier  to ensure correct documentation and data generation
II.Review of the submission and associated documents as per the current regulatory requirement to ensure the correctness of the same for compliance with the Regulatory Health authorities requirement of filing.
III. Evaluate  the  proposed  changes and highlight the category of the post approval changes throughout the  product life cycle to ensure the product quality is not  compromised, this helps to be in line with the current technology / requirement as a part of the regulatory  compliance and post approval changes.  IV. Maintain  Marketing  Authorisation  by  renewing  validity ensuring availability of product for placing in  market

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