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AGM / Sr. Manager - Regulatroy Affairs NMS Consultant

0.0 years

0 Lacs

mumbai, maharashtra, india

On-site

Role & responsibilities : Reviewing, verifying, and processing of all technical documents for accuracy before compilation or submission of dossiers as per USFDA & PEPFAR requirements. Review and regulatory compliance of Initial ANDA Documents like Trade dress, Q1 and Q2, bio-wavier, IIG clearance, MDD evaluation, Size and Shape, Elemental iron, Residual solvent, Elemental impurity and Exactable and Leachable impurity, Specifications [API and Finished drug Product), Master Formula (with respect to Bio-waiver), Stability Protocol, Labeling Information, Product development Report, Method Validation Report, BMR and BPR etc. Participate and represent as regulatory team in meetings (Level 1 and 2 ...

Posted 2 weeks ago

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