Regulatory Affairs Resume

Mital Modi

E-Mail address: ***********@*****.*** Contact: 201-***-****

CAREER OBJECTIVE: To obtain a challenging opportunity that will utilize my educational background and achievements by encouraging professional and personal growth. Moreover, I would like to help the society with my knowledge and by my profession.

EDUCATION:

Northeastern University College of Professional studies, MA Boston

April 2012

Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices GPA 3.80/4.0

Relevant Coursework:

New Drug Development: A QA/Regulatory Overview

Regulation of Generic Pharmaceutical and Biosimilar Products

Biologics Development

Practical Aspects of Regulatory Compliance

Biomedical Product Development: From Biotech to Boardroom to Market

Food, Drug, and Medical Device Law: Topics and Cases

Medical Device Development

Saurashtra University, Gujarat, India.

Bachelors of Pharmacy Grade: Higher First class

Presentation and Projects:

Filed a hypothetical IND Application, NDA application, pre-IND meeting Request, Special Protocol Assessment for FDA approved drug Zegerid OTC.

Prepared a Hypothetical Biologics License Application (BLA) for the FDA approved Product Provenge utilizing filling Form 356h.

Completed a class exercise on Failure Mode and Effect Analysis (FMEA) for medical device.

Prepared an Informed Consent Form for Hypothetical Resistant depression drug clinical trial.

Delivered a Seminar on Recombinant human erythropoietin

Attended a seminar ‘PharmaVision 2020’ about the future of the pharmacy field in the year 2020

Relevant Experience:

CAMBRIDGE Health Care Limited, Gujarat, India.

Position: Intern in Quality Assurance

Assisted with documentation and archiving records

Facilitated review and revision of Standard Operating Procedures and Batch Manufacturing Records.

Worked as a liaison between the quality control and quality assurance department

Provided support in compilation of common technical document and drug master file for Drugs.

Arihant College of Pharmacy and Bioresearch, Ahmedabad India

worked as an assistant lecturer

Skills:

Regulatory Law

Understanding of FDA, ICH, ISO 9001, ISO 13485, Quality Standards, Quality System Management and GHTF guidelines.

Post marketing surveillance, CAPA, Auditing and Risk Management.

Overview of Latin America, Canada, and Asian Medical Device Regulations.

Knowledge of IND, NDA/ANDA for Drugs and BLA for Biologics.

Overview of Premarket approval, PMA supplements, 510K/PMN, STED, and HDE for Medical devices.

Understanding and tracking of latest changes/ proposed changes to worldwide regulatory requirements related to products and processes.

Computer Skills: Proficient in MS-Office Suite Software.

References upon request:

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