Executive - Regulatory Affairs- US- Market Mumbai Extrius Consultants

5.0 - 10.0 years

6 - 9 Lacs

mumbai suburban, navi mumbai, mumbai (all areas)

Work from Office

Author high- quality CMC documentation for US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidance's assuring technical congruency and regulatory compliance. US submissions Required Candidate profile Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle. knowledge of CTD /eCTD for submission of dossiers B. Pharm / M. Pharm 5 - 8 Years

Posted Date not available

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Executive RA / Asst Manager Job Excel

5.0 - 10.0 years

3 - 8 Lacs

vadodara

Work from Office

Preparation, compilation, and review of dossiers for USFDA and ROW markets ANDAs, amendments, and deficiency responses for the USFDA. Strategize, plan, and oversee USFDA submissions – ANDA, PAS, Annual Reports, and post-approval changes.

Posted Date not available

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