Nikita Purav

CMC Drug Substance COOP- PepGen | M.S. in Regulatory Affairs -Biologics, Medical Devices and Drugs

Role
Cmc Process Development Coop at PepGen
Location
Boston, MA, US
LinkedIn followers
500 followers

About Nikita Purav

Regulatory Affairs and Quality Assurance professional with experience in IND/NDA/BLA…

Experience

  1. Cmc Process Development Coop

    PepGen

    Jul 2025 — Present · Boston, MA, US

    Implementing process development initiatives for process optimizationWorking on CMC sections of Module 3 of the IND submissionFacilitated making of risk assessment and process control strategy documentsRegularly reviewing CMC information in alignment with FDA and ICH guidelinesApplied ICH and FDA/EU Regulatory guidelines to implement Process development Initiatives

Education

  • Mumbai University

    Bachelor of Pharmacy - BPharm

    2020 — 2024

  • Northeastern University

    M.S in Regulatory Affairs- Drugs, Biologics and Medical Devices

    2024 — 2026

  • Children's Academy School

    10th ICSE

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Nikita Purav — Cmc Process Development Coop at PepGen in Boston, MA, US | Unifers