Education
Johns Hopkins University, Baltimore, MD
December 2013
Master of Science in Regulatory Science
cGPA-3.40/4.0
Relevant Courses - Introduction to Regulatory Affairs, Translational
Biotechnology; From Intellectual Property to Licensing, Bio-Organic
Chemistry, Introduction to Bioinformatics, Bioassay Development, Food and
Drug Law, Introduction to cGMP Compliance, Clinical Development of Drugs
and Biologics, Biostatistics, Bioprocesses in Regulatory Affairs, Practicum
in Bioscience Regulatory Affairs.
University of Mumbai, Mumbai, India
August 2008 - May 2012
Bachelor of Pharmacy
GPA-3.29/4.0
Internships/Training and Work Experience
Zimmer, Warsaw, IN. Jan
2014 - Current
Regulatory Affairs Associate
. Providing Regulatory direction to development teams as a core team
member.
. Involved in a Remediation Project.
. To review proposed product changes for impact on regulatory status of
the product.
Covidien, Mansfield, MA. May
2013 - August 2013
Regulatory Affairs Intern
. Worked on Multiple Projects.
. Involved in a 200% Labeling Project, the purpose of the project was to
outline the process and requirements for a 200% inspection of the
rebranded artwork to identify differences and determine if it can have a
Regulatory Impact.
. FDA Submissions Database Creation.
. Worked under the FDA e-copy guidance to communicate with the FDA for a
Pre-IDE Withdrawal.
. Involved in Strategizing a submission timeline and strategy for a product
under the DEHP Elimination Project.
The Johns Hopkins Medical Institutions, Welch Centre for Clinical Research
September - December 2013
January 2013 -
May 2013
Research Assistant
. Recruit Patients for a Phase II Study.
. Interview Respondents to obtain information for a large study for people
with kidney failure.
. Record data accurately on research forms.
LifeCell International Pvt. Ltd., Mumbai, India.
Business Development Executive
May 2012 - September 2012
. Delivered seminars on advantages of stem cells and recent developments
in treatment with stem cells at the national and state gynecologist and
obstetrician seminars
. Managed to develop effective business plans to raise the sales of the
company to 5% in six months
Hacettepe University, Ankara, Turkey.
Research Assistant, Pharmaceutical Technology Laboratory.
July 2011 - September 2011
. Formulated PLGA Nanoparticles with the Drug Paclitaxel using oil-in-
water emulsion solvent-evaporation method.
. The smallest nanoparticle size obtained was 137 3.8 nm and the
encapsulation efficacy was 46% and the production yield was 76%.
Asuwaldi Pharmaceuticals, Mumbai, India.
Intern
May 2011 - June 2011
. Worked as an intern in Packaging, Manufacturing and Quality Control
Departments.
. Oversaw the labeling process and drafted the protocols and manufacturing
records
. Assisted in writing QC testing protocols and reports
Mehta Chemist and Druggist, Mumbai, India.
June 2010 - August 2010
. Assisted in Sales, Marketing and Inventory Management.
Co-Curricular Achievements
. Paper Presentation of the Academic Research Project "Controlled Release
of Paclitaxel Using PLGA nanoparticles" at the 18th International
Symposium on Microencapsulation, Antalya, Turkey, September 12-14, 2011.
. Article in Quarterly e-Magazine 'Panache-live'.
. Article in SVKM's annual magazine 'Quest'.
. Business Plan Presentation at Rx- 2011, Mumbai, India.
. Oral Presentation 1st Place winner at SVKM's annual festival
'MANSHODHAN'.
Extra-Curricular Achievements
. Among only 14 Indian Students to be selected for the Student Exchange
Program (SEP) by International Pharmaceutical Students Federation
(IPSF).
. Secured the 3rd place all over India for National Tuberculosis Awareness
Campaigns performed during the year 2008-09 by Indian Pharmaceutical
Association - Students Forum.
. Won the first place all over India for organizing the best and most
effective anti-HIV campaign in the whole country.
. Winner of Personality Contest at Rx - Festival, Rx-2010 and Rx-2011.
. Selected as Associate Treasurer, 2010. Indian Pharmaceutical Association
- Students' Forum - Maharashtra State Branch.
. Selected as Associate Editor-in-Chief of the SVKM's annual Magazine
"Quest".
. Selected as Treasurer, 2011. Indian Pharmaceutical Association -
Students' Forum - Maharashtra State Branch.
. Selected as the General Secretary of Dr. Bhanuben Nanavati College of
Pharmacy, 2011-12.
. During the term as the General Secretary the college council, the
college won awards of "Best College Cultural", "Best College Sports" and
"The Best College all across Maharashtra State".