Hetero - Regulatory Affairs Role - Formulation/API

Regulatory Affairs Role - Formulation /API

- Coordinating and handling the compilation and submission of Post- Approval regulatory submissions, including Original ANDA (Oral Solid Dosage Forms).

- Compilation (eCTD format) & review of dossier (ANDA) for Solid oral products within stipulated time to get approval within timeline.

- Involving in review of drug substance open part of DMF Spec, STP & MVR/MTR.

- Review of Technical documents like Manufacturing & Packaging Records, API/FP Specifications and Stability Data.

- Coordinating and handling the compilation and submission of Original ANDS Submissions.

- Compilation (eCTD format) & review of dossier (ANDA) for Solid oral products within stipulated time to get approval within timeline.

- Involving in review of drug substance open part of DMF Spec, STP & AMVR/AMTR.

- Review of Technical documents like Manufacturing & Packaging Records, API/FP Specifications and Stability Data.

- CMC (chemistry manufacturing controls) document review & Product Development Report Review.