Namita Waghmode

About Namita Waghmode

I am a Regulatory Affairs professional with a Master’s degree in Drug, Biologics, and Medical Device Regulatory Affairs (International Concentration) from Northeastern University, Boston. With hands-on experience at industry leaders such as Siemens Healthineers and Renovia Inc, I bring a strong foundation in both U.S. and international regulatory frameworks.I have actively contributed to the preparation and review of QSR documents, SOPs, and regulatory dossiers, and I am well-versed in submission requirements across key global market including the US FDA, EU, Health Canada, Latin America, China, Japan, and Singapore.My professional experience includes developing strategic regulatory plans to support product entry into U.S. and international markets, ensuring compliance and efficient time-to-market. I possess strong working knowledge of 21 CFR Parts 200, 300, 600, and 800, and am committed to regulatory excellence in the healthcare and life sciences sectors.I’m passionate about contributing to innovative, patient-centric solutions through regulatory strategy and quality compliance.

Experience

1. Senior Regulatory Affairs Analyst

   Freyr Solutions

   Oct 2021 — Present · US

Education

• Prin K.M.Kundnani College of Pharmacy

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

  2012 — 2016

• Northeastern University

  Master's degree, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs

  2018 — 2020