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Project Medical

Location:
Boston, Massachusetts, United States
Posted:
October 05, 2013
Email:
ab9xqz@r.postjobfree.com
Contact Info:
***** ***** ********** ***********@*****.***


***** *****

*B Turquoise Way, Roxbury Crossing, MA 02120-2700 617-***-**** *****.*@*****.***.***

EDUCATION

NORTHEASTERN UNIVERSITY

Boston, MA

College of Professional Studies

August 2013

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

MANIPAL UNIVERSITY Manipal,

Karnataka INDIA

Manipal College of Pharmaceutical Sciences

June 2011

Bachelor of Pharmacy

MANIPAL UNIVERSITY Manipal,

Karnataka INDIA Manipal Life Sciences Center

August 2009 Certificate Course in

Bioinformatics

SKILLS AND ABILITIES

Regulatory Skills:

• Familiar with IND/IDE, NDA, BLA, 510(k) Premarket Notification, PMA, adverse event reporting (Form

3500A), GMP, GLP, GCP, corrective and preventive action (CAPA), labeling, ISO and SOP

• Knowledge of 21 CFR 820,814,812,201, 11, 312 and 202 and ICH

• Familiar with FDA letters, supplements and amendments

• Strong understanding of US and European regulatory processes for drugs and medical devices

• Strong understanding of clinical trials, informed consent document, regulations governing clinical trials,

material transfer agreements, 45 CFR 46, 21 CFR 50 and 56

Language:

• Fluent in Hindi and English

Computer Skills:

• Proficient in MS Word, Excel, PowerPoint and Outlook; Familiar with Bioinformatics Software such as

BLAST, FASTA and MySQL

Interests:

• Playing Chess, Swimming and Acting

RELATED ACADEMIC PROJECTS AND WORK EXPERIENCE

BRIGHAM AND WOMENS HOSPITAL

Boston, MA

Regulatory Document Specialist Jan 2013 –

June 2013

• Developed and managed systems and tools for collection, formatting, review and maintenance of

regulatory documents from clinical investigative sites

• Reviewed and submitted regulatory documents for US, Europe and Canada, particularly FDA Form

1572, CTAs and Financial Disclosure Form

• Assisted regulatory team on international and domestic regulations for the review and submission of

IND and NDA

• Performed QC review and electronic filing of regulatory documents and implemented corrective and

preventative action (CAPA) to fulfill gaps in compliance knowledge and practice

• Prepared audit reports and project summary reports for inspections by sponsor or agencies

• Organized internal and external team meetings to resolve regulatory queries from sites and sponsors

• Collected and submitted clinical trial dossiers update/information for four clinical trials

BOSTON SCIENTIFIC

Boston, MA

Internship in Global Regulatory Affairs Project Sep 2012 –

Dec 2012

• Worked as an instructor for international students enrolled in global regulatory affairs program

• Worked with Boston Scientific international regulatory team as well as Northeastern University on the

projects related to the course

• Ensured Regulatory Documents are in compliance with FDA Quality System Regulation, European and

Canadian Requirements

• Reviewed PMA Supplement for cardiovascular drug eluting stent

NORTHEASTERN UNIVERSITY

Boston, MA

Regulatory Affairs

• Completed projects on filing BLA, IND, NDA, IDE and PMA in a group of 3

• Studied detailed steps of filing 510 (k), IDE and PMA

• Filled out form 356h by detailed study and research of all the 19 sections

• Studied FDA guidance documents supporting the submission and approval of product

• Obtained labeling information from all possible resources and discussed its appropriate format and

procedures while filling BLA application

• Wrote Batch Manufacturing Record (BMR), Standard Operating Procedure (SOP) and labeling, according

to cGMP requirements

KASTURBA MEDICAL COLLEGE Manipal,

Karnataka, INDIA

Intern Hospital Pharmacist Dec 2009-

Jan 2010

• Completed 150 hours of hospital pharmacy training in pharmacy dispensing wing, OPD pharmacy and in

the manufacturing section of the pharmacy

• Read prescription and dispensed drugs ensuring accuracy and on time delivery

• Maintained accurate records of all drugs purchased and manufactured to keep inventory up to date

• Collaborated with deputy chief pharmacist to manufacture and package tablets, creams, lotions, detergents

and antiseptics

ADDITIONAL ACADEMIC EXPERIENCE

Manipal College of Pharmaceutical Science Class

of 2007

• Presented a poster, on a team of 2, on the topic “Study on therapeutic range of lamotrigine in Indian

epileptic patients” in the 62nd Indian Pharmaceutical congress Dec 2010

• Represented the class as Class Representative in class management, organizing interclass cultural and

sports events of year 2007-2008, organizing blood donation camps in our college

• Collaborated with student council to plan college events like Annual Day, Cultural and Sport Events

Manipal Life Sciences Center Feb 2009-

Aug2009

• Researched and completed project on the topic “Comparative genomic analysis of Down syndrome

Schizophrenia and Bipolar disorder on chromosome 21”on a team of 4

Industrial Tour

Feb 2011

• Visited manufacturing unit of “Astrazeneca” in Bangalore (India) and observed the manufacturing and

packaging of tablets, injections, capsules and syrup