Quality Assurance Medical Device

Objective

Seeking an opportunity in Regulatory Affairs and Clinical Research for

practical application and growth of my regulatory and scientific skills

in the Healthcare Industry.

Academics

Northeastern University, Boston, MA (Graduation Date: April 2011)

September 2009 - Present

Candidate for MS in Regulatory Affairs of Drugs, Biologics and Medical

Devices. GPA-3.95/4.0

(Relevant courses - Regulatory overview of New Drug Development, Regulatory

overview of Biologics, Regulatory overview of Medical devices, Global

Regulatory Affairs: Canada, Asia, Latin America, Human Experimentation,

European Union Compliance Procedures and Regulatory Affairs and Practical

Aspects of Regulatory Compliance.)

University of Mumbai, Mumbai, India.

August 2005 - May 2009

Bachelors in Pharmacy.

GPA-3.9/4.0

Experience

NxStage Medical, Inc, Lawrence, MA- Regulatory Affairs Intern

January 2011-Present

. Prepared and updated medical device submissions such as 510(k), EU

design dossiers, technical files and Canadian class 2 and 3

submissions.

. Worked on regulations for Venezuela, Singapore, Italy, Netherlands,

Sweden to implement product registrations in those countries.

. Worked closely with marketing and reviewed and approved product

labeling and advertising. Prepared an in-house SOP for global labeling

requirements.

. Part of a regulatory project developing new products and completing

Letters-to-file and regulatory path assessments.

. Advised regarding worldwide changes in regulatory requirements like

WEEE, radio and communications directives and communicated with the

regulatory agencies accordingly.

Pfizer Ltd, Mumbai, India - Research Intern

May 2008 - June 2008

. Involved in the Manufacturing, Packaging and Labeling of syrups,

tablets, capsules and dusting powders which were carried out in

accordance with FDA Standards.

. Observed the Quality Control processes and received training in QC and

QA procedures.

. Handled instruments like HPLC, GC, UV spec and IR.

Novus Pharmaceuticals Ltd, Mumbai, India - Quality Assurance Intern

May 2007 - July 2007

. Grasped all the regulations involved in GMP, IQ/ OQ/ PQ Validation

requirements.

. Understood the manufacturing of sterile powder formulations and API's.

Projects

BLA Submission

June 2010

. Prepared a BLA for a fictitious Bio-similar in accordance with 21CFR 312,

21CFR 600, 21CFR 601 and various ICH Guidances.

Informed Consent Document

June 2010

. Prepared an Informed Consent Document in accordance with FDA and ICH

Guidances.

Biologics Approval Process

March 2010

. Gave a powerpoint presentation on the approval process of Biologic

Generic and Combination products based on 21CFR 600 to 21 CFR 680.

IND submission

November 2009

. Prepared a mock IND for an anti-inflammatory drug in accordance with

21 CFR 312 and all relevant FDA and ICH Guidances.

Type B Meeting

November 2009

. Prepared aType B meeting request for an End of Phase 2 meeting with

FDA in accordance with 21 CFR 312.47 and relevant Guidances.

Biotransformation using Lipases

January 2008

. Assisted the research team on the use of lipase as a catalyst in the

development of drug or drug intermediates.

. Performed various Lipase enzyme catalyzed reactions to synthesize various

drugs.

Skills

Regulatory Skills: Knowledge and Understanding of NDA, BLA, IND, ANDA,

PMA, 510(k) and various FDA, EMA and ICH guidances. Competent in

researching various directives and guidances.

Computers : Proficient with Windows and MAC, Microsoft Word, Excel,

Access and Powerpoint, Internet.

Other Skills : Efficient in English written and oral skills, detail

oriented, excellent interpersonal skills, experience in group projects.

Contact this candidate