Project Manager

EDUCATION

Northeastern University, Boston, MA, USA April 2012

Masters of Science (M.S.) in Regulatory Affairs for Drugs, Biologics & Medical Devices Related Coursework:

Biologics Development, Medical Device Development, New Drug Development, Regulatory Overview Drug and Medical Device Regulation, Practical Aspects of Regulatory Affairs, Human Experimentation: Methodological Issues Fundamental to Clinical Trials, Managing International Clinical Trials, Food Drug and Medical Device Law.

Mumbai education Trust, Mumbai, India June 2009

Bachelors in Pharmacy

Related Coursework: Forensic Pharmacy and Drug Regulation, Hospital Pharmacy, Pharmaceutical Management, Pharmaceutics and Drug Delivery , Bio pharmaceutics, Pharmacology, Medicinal Chemistry, Pharmaceutical Analysis, Biotechnology.

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WORK EXPERIENCE

Cognizant Technology Solutions, Mumbai, Support Analyst Dec 2009 -July 2009

• Provided support for Clinical Data Management software to Novartis Doctors, Scientists, Researchers, Lab Technicians.

• Authorized end users to access Clinical Trial Data, Studies and Clinical Report Forms, Pharmacovigilance Data at various security levels depending on the user profile and designation.

• Documented the work flow operations & formed report on daily basis for current and future activities using Microsoft office- Word and Excel.

• Applications Supported: OC – RDC (Oracle Clinical – Remote Data Capture), ClinTrial, ClinAdmin CREDI, REDI, PREDI, TEDI, TMS and DMS.

Pharma Medico, Quality control and Quality Assurance Intern, Mumbai, India June 2008 - July 2008

• Worked in Analytical Department with Lidocaine, Anesthetic Gel as drug candidate.

• Conducted Quality control tests on raw material and finished products.

• Operated instruments like HPLC, UV Spectrophotometer, Granulators, Mixers and tube filing and crimping machines

• Performed validation checks on distilled water equipment for accuracy and precision.

• Executed line clearance tasks in packaging and labeling department.

• Prepared Batch Manufacturing Records and assisted in reviewing Standard Operating Procedures.

• Assisted with sampling, warehousing, dispensing raw materials used in formulation.

ACADEMIC PROJECTS

• Fictional IND: Created IND and NDA submissions for the drug Trilipix a product of Abbott Laboratories for lowering blood cholesterol, to simulate the actual regulatory submissions. October 2010

• Fictional PMA: Prepared a regulatory plan for execution, in order to bring a Class III device for long bone fracture in to market and also worked on submission special 510(k) in order to extend its indications of use. February 2011

• Manufacturing Exercise: Participated in manufacturing exercise of a drug product in simulated cGMP environment and Drafted a BMR and Testing protocol using tech transfer procedure. Exercised change control and QMS procedures. May 2011

• Regulatory Development Plan: Presented a paper on combination product containing Intravenous device, antibody monoclonal and an anti- inflammatory drug for the treatment of advanced stage of lung cancer. June 2011

• Drafted Informed Consent: Actualized an informed consent document as per 21 CFR 50.25(a) and 21CFR 50.25(b).

March 2011

• Poster Presentation: Presented a poster on Targeted Drug Delivery to the Brain at Indian Pharmaceutical Associations SF-MSB Technical Symposium 2009 February 2009

• Presentation: Presented a paper on Bioterrorism- A Threat January 2009

• Oral Presentation: Delivered an oral presentation on Dr. Reddy’s Polypills at Indian Pharmaceutical Associations SF-MSB Technical Symposium 2009 February 2009

SKILLS

Regulatory Affairs skills

• A good understanding of FDA and IRB regulations, ICH guidelines, GHTF Guidelines, ISO 9001, ISO 13485, Quality Standards and Quality System regulations

• A succinct understanding of various FDA regulatory submission like IND and NDA/ANDA for Drugs and BLA for Biologics and document management..

• An excellent knowledge of 510k, PMA, PMA supplements, IDE, HDE and STED submission for Medical Devices and In-Vitro Devices, Quality Management System and Compliance, Design Control.

• Knowledge of GCP, GLP, GMP standards, Advertisement and Labeling regulations, Regulatory Compliance, Post Licensure Requirements, including CAPA, MedWatch, OOS, Auditing, Risk management.

• A decent understanding of clinical protocol development, AEERS submission, Informed consent process, Ethical issues involved in clinical trials, Managing International clinical trials, Regulatory bodies of the globe, approval timelines and procedures for conducting trials in Asia, Latin America, Canada.

• A deep understanding of European Union product regulations, EU Directives, Approval procedures and timelines for Medical Device products- CE marking requirements.

• Knowledge of various stages of drug development form discovery to marketing and pharmacovigilace activities.

Computer Skills

• Wide range of knowledge of MS Word, MS Excel Spreadsheet, MS PowerPoint, MS Access Adobe Acrobat, Microsoft Outlook and Windows Operating System.

Professional Membership

• Regulatory Affairs Professional Society (RAPS) student member

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