Manjiri N.

About Manjiri N.

I\'m a Regulatory, Quality Assurance professional with 4+ years at the intersection of biotech, pharma, and medical devices — and I\'m passionate about : using technology to make quality systems actually work for the people who depend on them. I\'ve led end-to-end eQMS implementations, built training programs from scratch, authored SOPs and document management workflows, and supported FDA compliance across Biotech Organizations. What sets me apart: I don\'t just understand quality systems from the outside. I\'ve lived inside them — troubleshooting user issues before an audit, building the onboarding process that gets 40 new employees trained in their first week, and designing the document workflows. I\'m focused on the next frontier: AI-powered quality management — helping life sciences organizations move from reactive compliance to intelligent, automated quality systems that flag risks before they become findings.

Experience

1. Regulatory Affairs Fellow

   Dream Venture Labs

   Dec 2025 — Present · Boston, MA, US

   Serving as a Regulatory Affairs Fellow at Open Avenues Foundation — a nonprofit dedicated to bridging the gap between academic learning and industry-ready skills for university students across America. In this role, I design and deliver real-world FDA regulatory and quality training that gives students hands-on exposure they rarely get in the classroom, accelerating their readiness for careers in biotech, pharma, and medical devices.What I do:Architected an 8-week FDA Regulatory Essentials curriculum for partner university students, translating complex compliance frameworks into structured, outcome-driven session agendas with clear objectives and measurable in-class outputsDesign and lead sessions on for Biologics, Pharmaceuticals, and Medical Devices — grounding instruction in real industry business challenges rather than theoryThe bigger picture:Open Avenues Foundation partners with universities nationwide to give students — especially those from underrepresented communities — access to experiential learning that mirrors real workplace challenges. By contributing my regulatory expertise to this mission, I help ensure the next generation of RA/QA professionals enters the workforce with the technical fluency, confidence, and practical tools that a degree alone cannot provide. It\'s one of the most direct ways I can give back to a field that demands rigor.

Education

• Northeastern University

  Master's degree, Regulatory Affairs in Drugs, Medical Devices and Biologics

  2021

• Savitribai Phule Pune University

  Bachelor of Pharmacy - BPharm, Pharmacy

  2015 — 2019