Specialist, Regulatory Affairs FDF

Centrient Pharmaceuticals · gurugram, haryana, India

Location

gurugram

Job Type

Full-time

Posted

July 05, 2026

Job Description

Description  
Supporting the RA-FDF Team and contributing in the regulatory activities in order to achieve the objectives of the department which are: obtaining global approval for CENTRIENT products, including the lifecycle management of the registration dossiers according to business planning. 
Key Individual Accountabilities 
Collection of information and preparation of dossiers and variation packages as and when required. 
Compilation and update of the product dossiers in portfolio for global and for customers registrations (Both NP and LCM) under guidance from Portfolio Lead and RA managers 
Support in activities related to pharmacovigilance 
Support in evaluation of CMC data required to support dossiers and variation packages. 
Assist in the coordination of responses to questions raised by regulatory authorities during regulatory procedures 
Creation and updating of product information texts 
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