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    Sonali Lokhande

    Cerritos, California

    Scientific and Regulatory Writer

    Criterion Edge

    Specialties

    Life Sciences

    Where I've Worked
    C

    Sep 2018 – Jun 2019

    Scientific and Regulatory Writer

    Criterion Edge
    A

    Dec 2017 – Sep 2018

    Scientific and Clinical Data Analyst

    Adnab Research Inc
    K

    Dec 2011 – Dec 2017

    Graduate Research Assistant and Teaching assistant

    Keck Graduate Institute
    S

    Dec 2012 – Feb 2013

    Orphan Designation Application for Tay-Sachs Disease - FDA Regulatory Submission

    Sponsor - National Tay Sachs & Allied Diseases Foundation
    S

    Dec 2012 – Feb 2013

    Orphan Designation Application for Sandhoff's Disease - FDA Regulatory Submission

    Sponsor - National Tay Sachs & Allied Diseases Foundation
    A

    May 2011 – Nov 2011

    Technical Writer (Product Development)

    Anchen Pharmaceuticals
    K

    Sep 2009 – May 2011

    Regulatory Affairs Associate Center of Rare Diseases Therapies

    Keck Graduate Institute
    S

    Jan 2010 – Feb 2010

    Orphan Designation Application - FDA Regulatory Submission

    Sponsor - BPT Pharmaceuticals
    F

    May 2009 – Jul 2009

    US-FDA - Regulatory Affairs Intern at Office of Orphan Products Development (OOPD)

    Food and Drug Administration (USFDA)
    S

    Jan 2003 – Jan 2008

    Practicing Physician

    Self employed
    T

    Aug 2006 – Jan 2007

    Clinical Research Safety Associate

    Tata Memorial Hospital, India
    Where I've Studied

    2017

    PhD, Applied Life Sciences

    Keck Graduate Institute, CA

    2010

    MS, Clinical & Regulatory Affairs, Drug Discovery & Development

    Keck Graduate Institute

    2008

    Hospital & Healthcare Management

    Symbiosis Institute of Health Sciences

    2002

    Bachelors, Medicine and Surgery

    University of Pune

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