Nishchay Gupta

Regulatory Group Director - Medical Devices and Combination Products at Genentech

Role: Regulatory Group Director at Genentech
Location: Daly City, CA, US
LinkedIn followers: 500 followers

About Nishchay Gupta

Strong regulatory background with experience in combination products (CMC), small molecules (CMC) and Class medical devices.

Experience

Regulatory Group Director
Genentech
Nov 2024 — Present · South San Francisco, CA, US

Education

Manipal Institute of Technology
B.E., Biomedical Engineering
2005 — 2009
University of Southern California
Master of Science, Medical Devices and Diagnostics Engineering
2009 — 2011

Skills

Medical Devices
Quality Assurance
Gmp
Fda
Microsoft Word
Visio
Sop
Software Documentation
Iso 13485
R&D
Quality System
Quality Control
Fmea
Testing
Regulatory Affairs
Clinical Trials
Biomedical Engineering
Clinical Research

Contact information

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Work email
g••••••••@gene.com
Personal email
•••••@•••••.com
Direct dial
+16•••••••45

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Current company

Genentech

Biotechnology Research · 18K employees · Founded 1976 · South San Francisco, California, United States

About Genentech We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours. If you’d like to join our team, view our openings at gene.com/careers. Our patient resource center is dedicated to getting patients and caregivers to the right resources. You can reach them at 1 (877) GENENTECH (43•••83) Monday-Friday, 6am-5pm PST or p••••••••@gene.com. Community Guidelines: 1. We want to foster positive conversation around the issues we are passionate about. To that end, we remove profanity, content that contains threatening language, content that is aimed at private individuals, personal information, and repeated unwanted messages. 2. Don’t mention any medicines by name — ours or anyone else’s. Because of the fair balance rules governing our industry, we cannot post any comments that reference any pharmaceutical brand, product, or service. Please do not mention any specific medicines by name, or include any links to third party sites in your comments. 3. This isn’t the place to report or discuss side effects. This site is not intended as a forum for reporting side effects experienced while taking a Genentech product. Instead, you should report any side effects to Genentech Drug Safety at 18•••••••55. You can also report side effects of any prescription product directly to the FDA at 1-800-FDA-1088 or by visiting www.FDA.gov/medwatch. 4. Don’t pitch your product or service. Please don't use our page as a place to promote your product or pitch your services. Please also avoid posting links to external sites. We reserve the right to remove any posts that are deemed promotional.

gene.com

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About Nishchay Gupta

Experience

Regulatory Group Director

Education

Manipal Institute of Technology

University of Southern California

Skills

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