Posted:5 hours ago|
Platform:
Work from Office
Full Time
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
Otsuka Pharmaceutical India Pvt Ltd
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