Sr. Officer To Asst.Manager - Regulatory Affairs (Formulation & API) Dishman Carbogen Amcis

5.0 - 10.0 years

4 - 8 Lacs

ahmedabad

Work from Office

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 Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier. Assist in preparation of dossier as per country specific requirement. Any other job assigned by immediate supervisor/HOD Preferred candidate profile Hiring for API & Formulation background candidates for Regulatory Affairs Team Good Communication Skill in English

Posted 3 days ago

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