GAYATRI M. BHOJKAR

*** ********* ****, *** # ** Lowell, MA-01851 617-***-****

acrzg8@r.postjobfree.com LinkedIn: http://www.linkedin.com/in/gayatribhojkar

Education

Masters of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices GPA 3.71

Northeastern University, Boston, MA March 2015

Bachelor of Pharmacy GPA: 3.8

Pune University, India May 2012

Skill Set

In-depth knowledge about the IND, NDA, ANDA submissions

Knowledge and understanding of ICH, GCP, ISO guidelines

Annual report filing experience

Familiar with international regulations of the Canadian, Asian and Latin American countries

Professional Experience

Labeling Operations Specialist, SCIFORMIX CORPORATION on assignment to Pfizer Inc. Jun ’15- Present

Responsible for Creating and updating labels, Core Data Sheets, USPI, centralized SPC’s, Med Guides

Experience with GDMS and PfLEET system of Pfizer

Responsible and accountable for managing all timelines for assigned deliverables, ensuring that all labeling projects meet expected and SOP required milestones

Managing key interactions with internal Sponsor contributing groups, reviewers, approvers and other stakeholders as and when required

Responsible performing QC for workflow of the document. Performing final QC and submission to Sponsor within agreed upon timelines

Regulatory Affairs Intern, AREVA PHARMACEUTICALS, IN Jul-Dec 2014

Assisted with ANDA submission

Reviewed and revised the labeling and promotion material

Maintained document tracking system

Compiled Annual report filing

Assisted in set up of the Pharmacovigilance system

Compiled a letter for CBE-30 response

Supported in compiling dossier for the marketing drug in Costa Rica

Formulation & Analytical Research Intern, SUNOVION PHARMACEUTICALS, INC., MA Sep-Dec 2013

Assisted in the clinical research protocol assessment

Assisted in the formulation, preformulation research and analytical R&D

Handled independent assignments for Analytical and Formulation groups

Formulation &Analytical Research Intern, SPRINGBANK PHARMACEUTICALS, MA Jun-Aug 2013

Performed stability studies of the potent drug compound in various media according to the protocol

Trainee, SERUM INSTITUTE OF INDIA Jun-Jul 2011

Academic Projects

New Drug Development: Regulatory Overview

Regulatory Development Plan Outline for Januvia

Mock regulatory development plan outlined for the filing of an NDA for the treatment of Type-II diabetes mellitus

Canada, Asia and Latin American Regulatory Affairs

Regulatory Business Plan: Which country to go next- Australia or Canada

Market for the Class II 510(k) cleared device with ISO 13845 certification studied

Regulatory compliance for both countries and possible effective strategies presented

Studied UDI requirements for the relevant countries

Medical Device Development: Pre-market Regulatory Overview

Product: Blood Glucose meter

Authored regulatory strategy outlining device classification, target population and identified potential markets for product entry to facilitate planning for international registrations

Complied tech file to support notified body audit

Analyzed CDRH’s re-engineering initiatives and evolving Investigational Device Exemptions, Pre-Market Approval, 510 (k) application process, Product Development, Protocol Development and review processes.

“Isolation, characterization and evaluation of Caesalpinia pulcherrima as nasal mucoadhesive agent.” 2010

Source optimization done from ten potential mucoadhesive sources

Characterization and nasal gel formulation done using Felodipine as the API

Achievements

Recipient of the International Scholarship for the Study of International Regulatory Affairs Sep 2014

Northeastern University

Publication

Publication titled “Vigilant Medication”. The same was presented at Indian Pharmaceutical Congress (IPC) 2009, Ahmedabad, India. Dec 2009

Intense study of the causes of adverse drug reactions due to generic medication studied

The goal was to create awareness about safe use of prescription medication and prevent drug abuse

Summary

Detail oriented, self-driven and proactive professional with outstanding communication, negotiation and problem solving skills. Strong interpersonal skills with ability to work cross-functionally

Professional affiliations

Regulatory Affairs Professional Society (RAPS)

American Association of Pharmaceutical Scientists (AAPS)

Accomplishment

Selected to be a part of the Private Launch team of “People over Profit” book by Dale Partridge

1000 were selected from 2200 applicants

Read and reviewed the book

Provided inputs and suggested possible changes

Contact this candidate