Regulatory Affairs Associate

JobResponsibilities:

Dossier preparation/review as per country specific guideline/CTD guideline

Timely query response submission to Distributor/ MOH

Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement)

Preparation, review & release of artworks & sales order as per country approval

Variation documents preparation and filing as per country requirements

Timely dispatch of tender documents to country/parties as per deadline

Should be able to review & interpret the requirement as per country specific/ tender guideline/Query received from MOH

Should be able to review various plant documents for dossier preparation like Process validation, Stability study, PDR, Method validation, SOP, Drug Master File, BMR, APR etc.

Should be able to communicate with relevant functions for procurement of required regulatory documents

Should be able to communicate with relevant business partner at country