hr at TRIDENT LIFELINE PVT LTD
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Trident Lifeline - Regulatory Affairs Executive (1-3 yrs)
Job Description :
1. Preparation of Dossiers for Product Registrations in Asian, African and Latin American countries.
2. Preparation of Common Technical Documents (CTD) and ASEAN Common Technical Documents (ACTD).
3. Review of technical documents like FPS (Finished Products Specifications), Stability Data, COAs (Certificate of Analysis) etc
4. Assisting in obtaining appropriate regulatory compliance of pharmaceutical products by preparation of documents for obtaining requisite approvals
5. Preparation of Dossiers for Product Registrations with State Food and Drug Administration (FDA) and Central Drug Standard Control Organization (CDSCO)
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