Madhuri Tupe
CMC Regulatory Expert
- Role
- Regulatory Affairs Manager at Genpact
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Madhuri Tupe
Hi! I am a Senior Regulatory Affairs professional with over 20 years of experience…
Experience
Regulatory Affairs Manager
Oct 2013 — Present · Mumbai, IN
Managed a 6-member regulatory affairs team that ensured compliance with applicable regulations and standards for CMC review and variations, renewals and notifications to Europe authorities.• Developed strategies that addressed over 25 issues related to product development processes that impacted quality, safety, and regulatory requirements.• Prepared risk management plans. Annual reports and provided technical expertise in support of premarket submissions by drafting responses to over 70 FDA questions.• Supervised and trained 5 project teams to develop timelines for activities associated with regulatory filings, preparation of labelling changes, and training materials, boosting productivity.• Coordinated and prepared regulatory submissions for assigned projects and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Education
University of Mumbai
Certificate Course, Certificate Course in Advance Study of Regulatory Affair
2014 — 2015
University of Mumbai
Bachelor of Science - BS, Chemistry
1997 — 2000
Veermata Jijabai Technological Institute (VJTI)
Post Graduate Diploma, Post Graduate Diploma in Food, Drug & Cosmetic
2000 — 2002
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