Faculty - Drug Regulatory Affairs - Visiting Faculty - Remote Cliniminds

10 - 15 years

15 - 25 Lacs

Noida

Remote

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions

Posted 2 months ago

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Drug Regulatory Affairs Executive Sunways Bio-science Llp

3 - 8 years

3 - 5 Lacs

Gurugram

Work from Office

Preparation & Review of dossier in CTD, ACTD, ETCD format Preparation of dossiers of stability Data, Analytical method validation Preparing the SPC/SMPC as per country guidelines Preparation and Reviewing of documents COA as per the country guideline

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Regulatory Affairs Officer Immacule Life Sciences

3 - 6 years

3 - 6 Lacs

Ahmedabad

Work from Office

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

Posted 2 months ago

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