Vidita Desai

  • 38 Cliff Street, Apt # 2, Jersey City NJ

Seeking Regulatory Affairs position in your organization where my theoretical knowledge and my ability ass value.


  • Dynamic and result driven Individual Demonstrates an unerring eye for detail ability to continuously strive for improvement strong planning and organisational skills conscientious and meticulous individual excellent communication & interpersonal skills, deep analyzer, self confidence. Ability to conceptualize and think visually. Ability to work within a team or alone. Willingness to learn

Work History

Work History
Jan 2015 - Present

Teaching Assistant

Long Island University, NY
  • Assisting Professor.
  • Teaching-Preparation of lectures, leading discussion section
  • Conducting laboratory exercises, grading papers and documentation of records of Pharm.D students.
Jun 2015 - Sep 2015

Regulatory Affair Intern

Sannova Analytical Inc, NJ
  • Trained in Bio analytical data quality control, and data review.
  • Gets hands on  Bio analytical report preparation.
  • Learn the process of NDA and ANDA submissions and complete bio analytical services to support preclinical and clinical studies.
Sep 2014 - Dec 2014

Graduate Assistant

Long Island University, NY
  • Grading students for SAT, ACT Exams. Proctoring examinations of Undergraduate students
Jun 2013 - Dec 2013

Program Training 

Biocare Remedies, India
  • Performed sampling of analytical tests to ensure with Indian Pharmacopoeial Standards and accordance with cGMP


Jan 2014 - Dec 2015

M.S. in Drug Regulatory Affairs

Long Island University
  • Experienced with filing requirements for IND/NDA/BLA/IRB submissions.
  • Design a module on QBD also formed compliance strategy in semester project.
  • Prepared corrective and preventive actions on warning letter of Sandoz.
  • Familiar with medical device regulations (PMA, 510K, CLIA.).
  • Highly experienced with cGMP, GCP and GLP compliance.
  • Thorough understanding of ICH guidelines.
  • Knowledge of global CMC documentation systems and global CMC regulatory requirements.
  • Knowledge of international & domestic Regulatory Affairs
Jun 2009 - Jun 2013

Bachelor in Pharmacy

K.B. Institute of Pharmaceutical Education & Research
  • Learn fundamentals of Pharmacology, Medicinal chemistry, Pharmaceuticals and Pharmacognosy. 


  • ICH Guidelines
  • USA Drug Regulations
  • 21 CFR 312 & 314
  • JAPAN Drug Regulation
  • Patent Law 
  • Medical Device
  • CAPA Preparation


  • Protecting Human Research Participants
  • Introduction to FDA Human Drug Review & Approval Basics


  • Graduate Employment Award


  • HPTLC method development & validation of Baicalein in hydrolyzed n- butanol extraction of root bark of Oroxylum indicum.
  • Dew Point Method


  • President - International Student Association