Regulatory affairs, Drug Safety, QA

Knowledge Areas

US FDA regulations Regulatory ICH guidelines SOPs

IND submissions BLA

Drug development NDA ANDA GCP

process cGMP/GMP GLP CTD/ eCTD

Drug Master File Labeling Protocols Safety

Case processing Triage Safety databases

MS Word MS Excel reporting Adobe Acrobat

MS Power point

Education

Northeastern University

April 2013

Boston, MA, USA

Master of Science - Regulatory Affairs for Drugs, Biologics and

Medical Devices

University of Mumbai

June 2007

Maharashtra, India

Master of Science - Analytical Chemistry

University of Mumbai

June 2005

Maharashtra, India

Bachelor of Science - Chemistry

Continuing professional Education

WIPO Worldwide Academy

November 2008

Completion certificate in "General Course on Intellectual Property"

Professional Experience

Qtech Solutions Inc.

Somerset, NJ

Drug Safety Intern

April 2013- Sep 2013

. Received and processed ICSRs from clinical trials and spontaneous

reports

. Extracted relevant medical data from the medical information provided

. Assisted in Triage for seriousness, relatedness, and expectedness of

cases

. Data entry and case processing in compliance with SOPs and regulatory

requirements

. Reviewed cases for minimum criteria and determined clock start date and

type of case

. Generated well written, concise and accurate narratives for both

serious and non-serious cases

. Performed quality review of Med Watch form

. Reviewed the SAE report forms and determined discrepancies/queries

found

. Reviewed and identified SUSAR cases

Cipla Ltd

Mumbai, India

Analytical Chemist

June 2007 - June 2010

. Prepared, reviewed and edited departmental SOPs, Protocols and final

reports

. Assisted and resolved queries of Regulatory Affairs department in

reviewing the laboratory data for regulatory submissions

. Performed document reviews and quality assurance checks

. Assisted department during U.S. FDA audit, customer inspections and in-

house quality assurance audits

. Assisted Quality Assurance team in training junior staff and

maintained training records

. Worked collaboratively with Quality Assurance and R&D team for

analysis of in-process drug substances

Therapeutic Drug Monitoring Laboratory

Mumbai, India

Industrial Intern

May 2006

. Assisted in Bio-Equivalence and Bio-availability clinical studies of

drugs

. Assisted in quality control activities and documented reports of

studies

Reliable Analytical Laboratory

Mumbai, India

Industrial Intern

October 2005

. Laboratory testing of samples on various analytical instruments

Projects and presentations

. Developed regulatory approval pathway (NDA) for hypothetical drug

including CMC, preclinical studies, clinical studies, labeling, post

marketing surveillance and REMS

. Drafted a comprehensive BLA plan for an influenza vaccine along with

filling out the FDA 356h form

. Processed an hypothetical adverse event case by determining AE's/SAE's,

writing case narrative and manual filling of form Med Watch 3500A

. Presented a project on "An overview of Quality Management Systems: ISO,

cGMP and Q10"

. Prepared and presented a position paper on Bio-equivalence and Bio-

availability clinical studies of an antiviral drug

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