VISHAL KANANI

*** ******** ** *** # **, Boston, MA 02115 ● 213-***-**** ● k4192j@r.postjobfree.com

EDUCATION

University of Southern California (USC), Los Angeles, CA May 2011

Master of Science in Regulatory Science GPA – 3.66/4.0

University of Mumbai, India June 2009

Bachelor of Pharmacy

EXPERIENCE

Clinical Research Assistant - USC Keck School of Medicine (Division of Movement Disorders) Dec 2009 – Feb 2011

• Documented electronic Case Report Forms (eCRFs) through EDC systems like Inform and Clinphone and maintained a log of Serious Adverse Events through the FDA’s 3500A (MedWatch) form

• Managed and documented drug accountability. Compiled and maintained regulatory documents of various studies

• Attended study-start up activities and prepared and compiled regulatory documentation regarding the same.

Regulatory Compliance Assistant – USC Keck School of Medicine (Division of Psychiatry) Sept 2009 – Feb 2011

• Performed internal quality audits on regulatory documents of various studies

• Assisted in preparing an IRB application for a new study

• Submitted protocol amendments to the IRB of existing studies. Notified IRB of any reportable events.

Regulatory Research Intern – Renumed Pharmaceutical Labs, India May 2009

• Assisted in researching regulatory requirements of countries like Brazil, India and China

Summer Intern - Torrent Pharmaceuticals, India May 2008

• Acquired first-hand experience on the manufacturing and development of tablets, capsules and API’s (active pharmaceutical ingredients)

• Performed and reported quality checks of the labels and packages in the Quality Assurance Department

RELEVANT COURSEWORK

1. Regulation of Drugs and Biologics – IND (21 CFR Part 312), NDA (21 CFR Part 314)/BLA (21 CFR 601.2) in CTD format, CMC, ANDA, Annual Report, Safety Reporting

2. Clinical Trial Design and Statistical Analysis – Clinical trial design for neuropsychiatric and cancer conditions, validation, sampling, clinical trial design for generic drugs, statistical analysis of a study

3. Management of Clinical Trials – GCP-ICH Guidelines, Clinical Investigational Plan, Preclinical Testing, IRB compliance

4. Global Regulation of Medical Products – Regulatory requirements of various countries like Europe, Asia Pacific, Latin America

5. Regulation of Medical Devices and Diagnostics – 510k (21 CFR 807), PMA (21 CFR Part 814), IDE (21 CFR Part 812), QSR, MDR and Complaint Reporting

PROJECTS

IND Submission

• Prepared a mock IND submission as a team, primarily focusing on chemistry, manufacturing and controls of a drug product

Internal Audit Checklist

• Prepared an Internal Audit Checklist and identified quality documents pertaining to Process Qualification and Validation referencing to 21 CFR 820 and ISO 13485

505b (2) Application process

• Prepared a briefing package explaining the 505b (2) process specifically in terms of its submission content

Regulatory Strategy for orphan drugs

• Constructed a regulatory strategy for the marketing of a novel peptide for a start-up company under the orphan drug status. Identified the opportunities and the regulatory hurdles faced during marketing a drug using the orphan drug status

Regulatory Research of Brazil

• Researched the registration and regulatory requirements for marketing a combination device in Brazil

• Summarized the business opportunities and concerns facing a company for marketing its medical product in Brazil

Quality System Regulations, Popcorn Lab

• Drafted manufacturing SOP, validation report, Controlled Material Specifications Document, Work Order (Traveler) and final device specifications of a medical product

CERTIFICATES/TRAINING

• OCRA Training – Navigating CAPA • CITI HIPAA Privacy Certification

• DIA Training – IND Phase, CTD/NDA phase • CITI GCP Certification

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