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Executive - Regulatory Affairs - API - Navi Mumbai Titan Laboratories

5.0 - 10.0 years

3 - 5 Lacs

navi mumbai

Work from Office

Role & responsibilities 1. Knowledge on Regulatory guideline for API 2. Preparation, review & submission of technical documents / Dossier for regulatory & non regulatory markets. 3. Handling of customers & MOH queries. 4. Reviewing of Documents (Specification, MOH, AMV, development report, BMR, MFR, PrP/R & stabilities. 5. Knowledge on EU, ICH & EMEA guidelines. 6. Compilation of Modules 1,2,3 of initial marketing authorisation. 7. Publishing DMF in eCTD format & software handling. 8. Reviewing & preparation deficiency responses with team. 9. Knowledge of the analysis & synthesis process. SPOR, GPS tracing online & software knowledge.

Posted 2 days ago

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