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5 - 10 years
4.0 - 7.5 Lacs P.A.
Ahmedabad
Posted:2 months ago| Platform: 
Work from Office
Full Time
Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Any job assigned by immediate supervisor/HOD Preferred candidate profile Experience required - Pharma API background Perks and benefits As per industry
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