Drug Regulatory Affairs Graduate Student

HETA MEHTA

** *, ***** ******, ******, MA-*****.

https://www.linkedin.com/in/hetamehta

*****.**@*****.***.*** 857-***-****

EDUCATION

Northeastern University Boston, MA

Candidate for Master’s in Regulatory Affairs for Drugs, Medical Devices and Biologics GPA: 4.00/4.00 July, 2017

Relevant Coursework: New Drug Development, New Biologics Development, New Medical Devices Development, Human Experimentation, Clinical trial design optimization and problem solving Institute of Chemical Technology Mumbai, India

Bachelor’s in Pharmaceutical Sciences

GPA: 7.51/10.00 May, 2015

Activities: Member of Student Council, Literary Club, Art Club WORK EXPERIENCE

IPCA Pvt. Ltd. Mumbai, India

Apprentice Trainee May 2014 - July 2014

Assisted the product development officer in the Chemical Synthesis Research and Development department

Observed and understood the process of New Drug Development

Reviewed, compiled and recorded analytical testing data in the company database

Supported in analytical testing of the product using High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC) and Mass Spectrophotometer

MEHTA API Pvt. Ltd. Mumbai, India

Intern May 2013 - July 2013

Assisted in the quality control department with quality testing of Active Pharmaceutical Ingredients

Acquired the knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)

Reviewed the SOPs and tested products so as comply with the U.S., Indian or the British Pharmacopoeia

Analyzed the test results as per required specifications and documented them in the company database

Utilized U.V Spectrophotometer, Karl Fischer titration apparatus for analytical testing of drug product ACADEMIC PROJECTS

Mock Biosimilar Development Plan

Northeastern University, Spring 2015

Developed a biosimilar product development plan was per the section 351(k) of the PHS Act, considering all the FDA regulations and guidelines.

Mock Premarket Notification 510 (k) submission

Northeastern University, Fall 2015

Fabricated a 510 (k) premarket notification submission for the device SpyGlass DS Direct Visualization System that involved classification, demonstration of substantial equivalence and listing requirements as per 21 CFR 807 Regulatory Plan Development

Northeastern University, Fall 2015

Designed a Clinical and Regulatory Development Plan for the drug Indinavir Sulphate. Analyzed the drug and proposed a regulatory plan with an intention to market the drug in compliance with the FDA laws and regulations Buprenorphine: As a long term injectable

Institute of Chemical Technology, 2015

Hypothesized a novel drug delivery system for Buprenorphine; an analgesic drug Physical methods for gene delivery: Its limitations and solutions to resolve them Institute of Chemical Technology, 2014

Wrote a review paper on the physical techniques for gene delivery and proposed solutions to resolve the problems SKILLS

Computer Systems: Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Adobe Acrobat Additional Skills: Acquaintance to ICH guidelines, Clinical protocol writing, Couch consent forms, Understanding of IND, NDA, ANDA, BLA, PMA and 510(k), Quality System Regulations, FAERS and AE reporting, eCTD, eTMF, Research/Investigating, Technical writing, Editing, Strategizing.

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