Responsible for compilation & submission of Dossier of a generic drug.
Hand on experience in Filing dossiers to regulated, emerging and ROW markets.
Experienced in CTD/ACTD and Regional Module.
Experience in Filing in EU, ASEAN, MIDDLE EAST, CIS AND LATAM regions.
To obtain approvals for relevant product marketing, Registration Certificates and export permission.
The Responsible for task involving evaluating dossiers/queries and compilation of critical dossiers and queries, as and when required. This includes search/retrieval/editing of data logically for preparation of dossier/query.
Will be responsible for maintaining high moral/discipline and secrecy of the
Regulatory Affairs Department with effective correspondence / liaison with manufacturing plants for timely procuring the required data for dossier preparation.
Experience with Injectable is a must.

A combination of medical devices and pharma will be a plus.

📌 Manager Dra Row New Delhi (India)
🏢 Curiza Life Sciences
📍 India