Job Title: Manager Regulatory Affairs API
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