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Regulatory Affairs Professional

Location:
Oz
Posted:
September 13, 2010

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Resume:

SMITA H. GEHANI

***** **** ******, ***** ****, Queens, NY 11417 909-***-**** ertz14@r.postjobfree.com

EDUCATION

Long Island University – Brooklyn, NY Jan 2009 – Expected Dec 2010

Master of Drug Regulatory Affairs

GPA: 3.83

Minor: French language

Relevant coursework: Biostatistics, Drug Regulatory Affairs, Pharmaceutical Labeling, Advertising and Promotion, Seminar in Social and Administrative Sciences, Regulation of OTC Drugs, Medical Devices, Cosmetics and Animal Drugs, Principles and Practices of Regulatory Compliance and Enforcement, Mechanics of Preparing INDs and NDAs and Pharmaceutical Industry

NIH Clinical Research Training Course, MD August 2010

Mumbai University, Maharashtra, India June 2008

Bachelor of Science in Pharmaceutical Sciences

Relevant coursework: Pharmaceutics, Pharmaceutical Management, Forensic Pharmacy, Hospital Pharmacy, Pharmacology, Biotechnology, Microbiology, Pharmaceutical Analysis, Biochemistry, and Pharmacokinetics

WORK EXPERIENCE

Benjamin Banneker Academy- Brooklyn, NY

Teaching Assistant Oct 2009 – Present

Guided students with Physics problems, laboratory work, and day to day course work

Higher Education Opportunity Program, Long Island University - Brooklyn, NY Teaching Assistant Aug 2009 – Present

Helped undergraduate students with Chemistry laboratory reports, and problem solving with emphasis on organic and inorganic chemistry

Everest Institute. Mumbai, India

Professor Feb 2006 – April 2008

Instructed and trained undergraduates to handle instruments in the laboratory and to perform experiments

Cipla - Mumbai, India

Trainee/ Intern May 2007 – June 2007

Received training in GMP Regulations, Quality Assurance, CMC and handled instruments including UV Visible spectroscopy, Gas Chromatography, Differential Scanning Calorimetry, Thermo gravimetric analysis

Leonard Chemicals Pvt.Ltd.India

Management Assistant Jan 2004 – March 2006

Recorded sale of drugs, maintained BMR, GLP and GMP documents

PRESENTATIONS

Prepared an IND for a fictitious drug May 2010

Impact of Personalized Medicine on Pharmacy Practice April 2009

The Over the Counter Pharmaceutical Industry in the World March 2009

Impact of Medicare Part D on Patients Feb 2009

Clinical Trials on Cancer Dec 2006

Aloe Vera – A Boon to Mankind Feb 2006

COMPUTER SKILLS

Microsoft Word, Microsoft Excel, PowerPoint, SPSS (Statistical Analysis Software), Windows OS



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