Quality Assurance Medical Device

Bhargavi Pandit

** ******** **** **, ******. MA- 02115

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

OBJECTIVE

I wish to deploy my Regulatory and Quality knowledge to ensure

success for the company and health-care system.. EXPERIENCE

REGULATORY AFFAIRS CO-OP (GENZYME)

January2013-June 2013

. Working with the rare disease group in Regulatory Affairs at Sanofi-

Genzyme and dealing with their products such as Cerezyme, Myozyme,

Aldurazyme, Lumizyme, and Fabrazyme for disease conditions such as

Fabry's disease, Pompe's disease, Gaucher's disease

. Assisted in filing for an NDA submission for Eliglustat using CITRIX

and submitted an Orphan drug annual report for Eliglustat.

. Contributed in reviewing NDA and IND submissions and submitting via

eCTD.

. Performed GAP analysis on all the labels in USA versus EU and have

knowledge on labeling requirements by the FDA and also well versed

with all labeling requirements in USA, EU and Other countries.

. Well versed with all labeling requirements for global submissions and

presented a paper on current labels.

. Contributed in a pre-NDA meeting briefing package for eliglustat and

created an Eliglustat correspondence binder including all the key FDA

communications

. Drafted a paper Breakthrough Act by FDA for Niemann-Pick disease and

on Compassionate use of products in USA and EU.

. Filed a form 1571 and 1572 submission to the FDA for various protocol

amendments and other procedures and written cover letters and filed

form 3204 for the same.

. Contributed in filing the Orphan drug Annual Report to the FDA and

also working on an individual project for all orphan drugs approved in

the market. And written cover letter for the report.

. Created a SharePoint website for the team.

BIOPHARMACEUTICAL QUALITY ASSURANCE CO-OP (GLAXOSMITHKLINE) July 2012-

Septemver 2012

. Designed a QA huddle board for the BioPharm team. Worked with

TrackWise and CDMS to document Master Batch Records.

. Co-authored in an industrial paper on "Regulatory Approvals for

Biosimilar and challenges" for the company in an international

journal.

. Created SOP and workflows for QA purposes. (Document control).

. Worked on change controls, deviations and batch record reviews. CGMP

trained through my Learning.

. Yellow-belt trained for SIPOC, Root cause Analysis, GEMBA, S5, Process

Mapping and other modules.

. Trained in using lotus notes and can also operate projects in EDMR

along with Quality control testing of documents.

. Reviewed IND submissions and been a part of the back room and control

room during a Pre-Approval Inspection for Albiglutide.

. Compared the outline of BLA of Albiglutide with ICH guidelines and

made a discrepancy report.

. Contributed in preparing data package for Type C Pre-BLA meeting for

Albiglutide.

INTERNSHIP -REGULATORY AND QUALITY DEPARTMENT (INDIA) April

2010-June 2010

. Worked as an intern in Kalindi Medicure (a subsidiary of Unichem) for

Quality, Manufacturing, Packing and labeling department.

. Assisted the team in documentation and record keeping work and helped

in inventory control and data recording.

. Worked in the Regulatory department and also have CMC experience

related to Regulatory Affairs.

EDUCATION

Northeastern University, Boston, MA

Master of Science in Regulatory Affairs for Drugs, Biologics and Medical

Devices May 2013

Related Courses: Introduction to Regulatory Affairs, New Drug Development,

Biologics Development, Medical Device Development, European Union

Compliance Process and Regulatory Affairs, Practical Aspects of Regulatory

Compliance, Regulatory Affairs Strategic Planning and Project Management

Mumbai University, India

Bachelor of Pharmacy

May 2011

PROJECTS AT NORTHEASTERN UNIVERSITY

. Worked on a Pre-IND submission for an orphan drug for Wilson's

disease. Also worked on developing a regulatory strategy for the

orphan drug and SPA for carcinogenicity for the same drug.

. Position paper on- CLINICAL RESEARCH IN USA VERSUS CLINICAL RESEARCH

IN INDIA

1. Presentation on conducting clinical trials in two different

countries.

2. Challenges to be faced and the country specific regulations.

3. Approval time frames Regulatory considerations for different

countries.

. Position paper on- CLINICAL RESEARCH IN PEDIATRICS

1. The difficulties faced in the trials and how they can be curbed.

2. Why are children treated as small adults and how can the status

quo be improved and FDA efforts for the same.

. PRESENTATION ON Q10 SYSYTEMS, ISO, GMP AND CGMP FOR COMBINATION

PRODUCTS

1. Overview of all the systems and Similarities and Differences

between the systems.

2. Laws related to all the systems and applicability.

SKILLS

. Computer Skills: Windows, Microsoft Office (Visio, Word, Excel,

PowerPoint, Outlook), Adobe/Acrobat Pro.

. Professional Skills: IND, NDA, ANDA, BLA, Informed Consent, Warning

letters responses, eCTD filing, Form 1571, EU and US regulations.

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