Customer Service Project Management

Saurabhkumar Indravadan Bhatt (Saurabh)

* ******* **. *** *, Boston, MA 02120 857-***-**** *****.**@*****.***.***

Education

Northeastern University, Boston, MA April 2016 - March 2018 Candidate for MS in Drug Regulatory Affairs

University of East London, London, United Kingdom August 2008 - May 2010

BS in Pharmacology

Hertfordshire Institute of Business & Technology, Hatfield, United Kingdom November 2006- May 2007

Certificate in Life sciences

K.L.E`s S.V.V.P School of Pharmacy, Bangalore, India November 2003- October 2005

Diploma in Pharmacy

Current study at Northeastern University

Device Development: Regulatory Overview (RGA 6202), Drug and Medical Device Reg. (RGA 6100)

Human Experimentation (BTC 6210), Validation & Auditing Clinical Trial (BTC 6211)

New Drug Development: Reg. Overview (RGA 6201)

Strategic Planning and Project Management for regulatory Affairs (RGA 6210)

Biologics Development: A Regulatory Overview (RGA 6200) with an average 3.14 GPA

Managing International Clinical Trials (RGA 6228) (in progress),

Introduction to Canadian Asian & Latin American Regulatory Affairs (RGA 6223) (In progress)

Technical &Commercial Knowledge

Study skill area: IDE, 510 k, PMA submissions as well as Quality system regulation & Post market surveillance,

21 CFR 812, 21 CFR 820, 21 CFR 801, 21 CFR 803, ISO 13485 Global Medical

Device submissions, Project management & Strategy overview

IND, NDA submission for Drugs as well as CTD, GLP & GCP aspects for regulatory compliance

21 CFR 201, 21 CFR 312, 21 CFR 314, OTC FDA regulation & cGMP regulations.

Informed consent process, Clinical Trial registration process and brief introduction about EDC,

21 CFR 11, 45 CFR 46, ICH Guidelines, BLA submissions and strategic project management

Languages: English and French (Primary intermediate)

Technical: Various dispensing technique along with dosage counting, Side effect & accuracy measurement

Commercial: Rate Negotiations, Vendor Development, Customer Service, telephone handling, report running &

General office work, stock taking

Relevant Experience

Snell Library, Northeastern University, Boston May 2016-September 2016

Stacks Assistant

Sorting of the books and Journals according to their coding

Arrange them and shelf them as per the coding instructions of the library

Zydus Hospitals & healthcare research Pvt Ltd, Anand, India July 2014 - March 2016

Pharmacist

Key role was to dispense medicines, devices and perform accuracy checking. Also create invoice through hospital I.T system for indoor patient.

Prepare inventory report monthly product consumption reports for medical devices and make Goods receive note of purchased medicines and devices.

Prepare stock reports for both drugs and devices.

Additional Certifications: DELF for French Level A2 Completed, SAS beginner under progress

SSN - Available Driver License: Available

Reference – Available Upon request

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