Jay Samudralwar Email & Phone Number

Vice President, Regulatory Affairs - CMC @ Syner-G Pharma CMC Consulting, LLC

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Jay Samudralwar Location

Hatfield, PA, US

Jay Samudralwar Work

2022 - now Vice President, Regulatory Affairs - CMC @ Syner-G Pharma CMC Consulting, LLC
2012 - 2015 Associate Director, Global Regulatory and Conformance @ Pfizer
2006 - 2011 Manager and Sr. Manager, Global Regulatory and Conformance @ Pfizer

2000 - 2006 Senior Regulatory Scientist, Regulatory and Analytical Sciences @ Merck
1998 - 2000 Sr. Validation Scientist @ Pfizer
View Department
1996 - 1998 Bioanalytical Scientist @ Merck
1993 - 1996 Supervisor @ Disease Diagnostic Laboratory, Univ. of Kentucky

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Jay Samudralwar Education

University of Kentucky, Lexington, KY
Research Associate (Analytical & Nuclear Chemistry)
1990 - 1993
Nagpur University, Nagpur
M.Sc. / Ph.D. (Analytical & Nuclear Chemistry)
1984 - 1990

Jay Samudralwar Skills

Regulatory, CMC & Conformance
Pharmaceutical Industry
Pharamceutical & Biotech products NDA, ANDA, DMF, IND, IMPD, GDUFA

MAAs
CTD
eCTD
Preparation of supplements / Variations in eCTD format
Pharm & Biotech product regulations in US, EU, AP/LA, Middle east, Japan
Injectable, lyophilized, frozen, solid and liquid drug products
LIMS

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Jay Samudralwar Summary

Jay Samudralwar, based in Hatfield, PA, US, is currently a Vice President, Regulatory Affairs - CMC at Syner-G BioPharma Group. Jay Samudralwar brings experience from previous roles at Pfizer Inc., Merck & Co. and Wyeth-Ayerst,. Jay Samudralwar holds a 1990 - 1993 Research Associate in Analytical & Nuclear Chemistry @ University of Kentucky, Lexington, KY. With a robust skill set that includes Regulatory, CMC & Conformance, Pharmaceutical Industry, Pharamceutical & Biotech products NDA, ANDA, DMF, IND, IMPD, GDUFA, MAAs, CTD and more. Jay Samudralwar has 4 emails and 2 mobile phone numbers on RocketReach.

Jay Samudralwar Emails

Found 4 emails

Jay Samudralwar Phone Numbers

Found 3 phone numbers

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Jay Samudralwar

Vice President, Regulatory Affairs - CMC at Syner-G BioPharma Group

Hatfield, PA, US
4
- synergpharma.com
- gmail.com
- msn.com
- aol.com
3
- +1 215-353-XXXX
- +1 215-412-XXXX
- +1 215-272-XXXX
Jay Samudralwar

Regulatory Scientist at Pfizer Pharmaceuticals

Hatfield, PA, US
3
- pfizer.com
- msn.com
- pfizer.co.uk

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Jay Samudralwar

Vice President, Regulatory Affairs - CMC at Syner-G Pharma CMC Consulting, LLC

Hatfield, PA, US
4
- synergpharma.com
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- msn.com
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- +1 215-353-XXXX
- +1 215-412-XXXX
- +1 215-272-XXXX
Libby Russell

Vice President at Syner-G Pharma CMC Consulting, LLC

Denver, CO, US
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Marsha M

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