
Sr. Officer To r
6 days ago
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
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