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Bangladesh - Dhaka, Bangladesh | Full Time | Confidential
Responsibilities & Context
Semi Regulated ROW Market (Asia, Africa, Latin America, Middle East, CIS)
Perform functions like Regulatory compliance, CTD filing, planning, meet project timelines.
Dossier preparation and review as per country specific guideline/CTD guideline·
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.
Ensure compliance of products with the current regulations, monitoring of international legislation, guidelines and customer practices, planning and communicating with external agencies.
Anticipate regulatory obstacles for trouble-shooting in development activities and emerging issues throughout the product lifecycle.
Handle post-approval variations, support for smooth launch and uninterrupted supplies.
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