Regulatory Affairs / Clinical Research

AMIT GUPTA

*********@*****.*** • 408-***-**** • Sunnyvale, CA 94087

linkedin.com/in/amitgupta1988

EDUCATION

Master of Science in Regulatory Affairs

Long Island University, Brooklyn, NY, May 2015

Bachelor of Pharmacy

Mumbai University, Mumbai, India, May 2011

SUMMARY

2.5 Years of combined experience in Drug Safety Reporting and Regulatory Affairs

Prepared and assisted Regulatory Submission. Drafted templates for regulatory submission and arranged meetings for the regulatory team as per everyone availability

Ability to prepare INDs, Annual Reports and AE Reports. Knowledge of FDA approval process, Trial Master File (TMF), Informed Consent Form, 1572 Form, IRB Submission, NDA, ICH, cGMP

Knowledge of Clinical Trial Start up and Close-Out Visits, Structured Product Labeling (SPL), Amendments and Supplements, Requirements on Pharmaceutical Labeling and Drug Advertisement, Enforcement Actions like 483s, Warning letter and Recall

PROFESSIONAL EXPERIENCE

Duke Translational Medicine Institute Regulatory Affairs Remote Internship Jan 2015 - Feb 2015

Received training on IND Submission and Pre-IND Meeting Briefing Packets

Gained knowledge of IND exempt submissions request

Utilized knowledge of 21 CFR part 50, 56, 211, 312 and GCP guidelines

Pharmacyclics, Sunnyvale, CA Regulatory Safety Intern (Oncology) Jun 2014 - Aug 2014

Prepared narrative template for clinical safety and efficacy narratives

Reviewed source documents (e.g. tables, figures, listings, narrative event trackers, individual case subject reports) and wrote clinical safety and efficacy narratives for registrational study in Waldenstrom’s Macroglobulinemia and for a phase 2 study in Diffuse Large B-cell Lymphoma

Worked with cross-functional teams with Biostatistics and Clinical Operation for completion and comparison of data cleaning and source documents

Presented presentation to the Regulatory team on Breakthrough Therapy Approval Process in USA

Cognizant /Novartis, Mumbai, India Drug Safety Associate Jun 2011 - Aug 2013

Performed triage, initial checks, search database to prevent duplicate entries, created case file and initialize received drug safety reports in the Argus safety database

Wrote, edited or summarized of Individual Case Safety Reports (ICSR) including spontaneous case reporting, Medical/Scientific literature cases, PMS study reports in MedWatch

Coded adverse events (AE) utilizing MedDRA including clinical narrative writing in accordance with company standard operating procedures (SOPs)

Managed and identified clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up requests as needed

Received quarterly honor award from global PV head for best quality deliverance

CLASS PROJECT

Long Island University, Brooklyn, NY Regulatory Project Manager Nov 2014 - Dec 2014

Prepared an IND for fictional drug Seniger

Drafted strategy on IND and pre-IND meeting

Responsible for writing Modules I and II along with compilation of other modules in CTD format

PRESENTATION

Delivered a presentation on Off-label use of drugs

Gave a presentation on Expedited Drug Development Pathways in US

Presented a presentation on REMS vs RMP

CERTIFICATIONS

Professional Certificate on Protecting Human Research Participants from National Institute of Health (NIH), Jan 2015

Professional Certificate on Introduction to FDA Human Drug Review & Approval Basics from FDA, Jan 2015

COMPUTER SKILLS

Proficient in Microsoft Word, Excel, Outlook and PowerPoint

Proficient in Adobe Acrobat, Argus, Lotus and SPSS software

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