Regulatory Affairs graduate

ALOMI MISTRY

*** ******** ******, #*, ******, MA 02115 *****.******@*****.*** 732-***-****

EDUCATION:

Northeastern University, Boston, MA June 2015

Candidate for Masters of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices GPA: 3.83/4.0

Global Biotechnology Product Registration:

o E.U., U.S., Japan, Canada Product Regulation

Advertising and Promotion of Drugs and Medical Device Products

o Off-label promotion, False Claims Act, Anti-Kickback Amendments

Validation and Auditing of Clinical Trial Information

Institute of Chemical Technology, Mumbai, India June 2013

Bachelor of Pharmaceutical Sciences GPA: 3.93/4.0

Awards:

Ratan Tata scholarship for merit (2011 – 2012)

Institute of Chemical Technology scholarship for merit (2012 – 2013)

SKILLSET:

FDA submissions: IND, NDA, PMA, BLA, IDE and 510(k)

Laws: Food, Drugs, Biologics, Tobacco and Medical Devices, advertising, labeling and promotion,

human experimentation, informed consent, IRBs, global biotechnology product registration

Guidelines and Regulations: CTA, ICH, CTD, GCP, GMP, GLP, CFRs, QSR

Adverse Events Reporting System of Drugs

Quality Control studies: Absorption studies, Differential Scanning Calorimetry, Chromatographic

techniques, Titration studies, Microscopy, Mass Spectroscopy

Quality Assurance: SOP, Validation studies and Validation protocols

HIPAA training and compliance

EXPERIENCE:

CVS Pharmacy, South Boston, MA August 2014- Present

Pharmacy Technician

Worked at Prescription pick up, production and drop off stations

Cheryl Laboratories Pvt Ltd, Mumbai, India

Summer Internship May-June 2012

Training in Quality Assurance Department

NGO Shraddha, Mumbai, India

Volunteer June-August 2013

Help autistic people by teaching them crafts

NGO YUVA, Mumbai, India

Volunteer January-April 2011

Rehabilitation of slum dwellers

ACADEMIC PROJECTS:

Clinical Drug Development plan on an antidepressant drug

Law review article on ‘Off-label promotion of prescription drugs’

Drafted a mock informed consent form, 510 (k), NDA and BLA

Formulating a hypothesis on ‘A Novel approach for Levodopa - induced Dyskinesia.’ Literature Research and

presentation

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