Jigisha Varia RAC

Jigisha Varia RAC

Director, Regulatory Affairs @ Novo Nordisk

About

A highly motivated, results-oriented regulatory professional with significant experience in regulatory affairs and R & D (Formulation Development) combined. Demonstrated strength in developing and execution of regulatory strategies to support various stages of drug product development with successful track records. Enthusiastic and determined, with outstanding interpersonal communication and presentation skills.

Country

United States

City

Princeton

Industry

Pharmaceuticals

Skill

Regulatory Affairs, ANDA, Regulatory Submissions, Pharmaceutics, eCTD, Sop, CMC Regulatory Affairs, Generic Drugs, cGMP practices, Drug Development, FDA, Technology Transfer, SPL, Project Management, Recalls, Formulation, SOP, GLP, Validation, Pharmaceutical Industry

Experience

Novo Nordisk

Director, Regulatory Affairs

Novo Nordisk

LinkedIn
2022-7 - Present · 4 yrs 3 mos

New Jersey, United States

Antares Pharma Inc.

Director of Regulatory Affairs

Antares Pharma Inc.

LinkedIn
2020-9 - 2022-7 · 1 yr 11 mos

Princeton, New Jersey, United States

Hengrui Pharma

Associate Director Regulatory Affairs

Hengrui Pharma

LinkedIn
2016-2 - 2020-9 · 4 yrs 8 mos

Greater New York City Area

Hengrui Pharma

Senior Manager Regulatory Affairs

Hengrui Pharma

LinkedIn
2015-5 - 2016-1 · 9 mos

Greater New York City Area

SUN PHARMA

Manager Regulatory Affairs

SUN PHARMA

LinkedIn
2013-7 - 2015-4 · 1 yr 10 mos

Greater New York City Area

SUN PHARMA

Senior Associate, Regulatory affairs

SUN PHARMA

LinkedIn
2011-6 - 2013-6 · 2 yrs 1 mo

Greater Detroit Area

Revogenex Inc

Senior Regulatory affairs/Product development

Revogenex Inc

LinkedIn
2009-2 - 2011-6 · 2 yrs 5 mos
Alembic Pharmaceuticals Limited

Senior Research scientist

Alembic Pharmaceuticals Limited

LinkedIn
2004-2 - 2008-3 · 4 yrs 2 mos
SUN PHARMA

Research associate

SUN PHARMA

LinkedIn
2001-9 - 2002-3 · 7 mos

Education

University of Southern California

University of Southern California

LinkedIn

Regulatory and clinical affairs

2022-4 - 2023-7 · 1 yr 4 mos
The Maharaja Sayajirao University of Baroda

The Maharaja Sayajirao University of Baroda

LinkedIn

pharmaceutics

2002 - 2004 · 2 yrs

Jigisha Varia RAC's Contact Information

Email

******@***.com

Phone

(**) *** ****

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