Clinical Research Quality Assurance

Somesh Milind Gupte

Contact: 857-***-**** email: ***************@*****.***

LinkedIn: www.linkedin.com/in/someshgupte

Professional Summary

Highly motivated and focused regulatory affairs professional with experience in Quality Assurance, Regulatory Affairs and Clinical Research. Demonstrated effective skills as a leader and strongly reliable with proven track record of managing people. Efficient multitasker and team player with ability to work in a fast-paced environment. Result oriented with focus on continuous improvement in quality and regulatory compliance.

Skill Set

Education

Masters in Regulatory Affairs for Drugs, Biologics and Medical Devices Dec 2017 Northeastern University, U.S.

Relevant Courses: Medical Device Development, New Drug Development, Biologics Development, Global Biotechnology Product Registration, Canadian and Latin American Regulations, European Union Compliance, Safety Sciences and Biomedical Product Development.

• Simulated a Traditional 510(k) submission for a MicroTaper Introducer Set.

• Authored summaries for PMA and IDE submissions.

• Prepared a mock IND submission in CTD format for the drug Farydak by Novartis.

• Drafted mock Pre- submission letters and CMC module for NDA submission.

• Drafted IND label, Clinical Trial Protocol, Informed Consent form, Clinical and Nonclinical and Pre-IND meeting request.

• Drafted end of phase 2 (EOP-2) meeting request for the biologic along with the meeting expectations.

• Researched and summarized the expectations for the development Phase III biologics and BLA submission. Bachelors of Pharmacy Jul 2014

University of Mumbai, India

Relevant Courses: Pharmaceutics, Clinical Pharmacology, Pharmaceutical Management, Psychology and Sociology. Experience

Brigham and Women’s Hospital– Boston, MA

Clinical Trial Protocol Coordinator (Safety) Feb 2017 to May 2017

• Performed triage of SAE reports for initial assessment.

• Assessed AE reports/source documents for completeness.

• Handled/distributed routine questions from sites regarding query processing.

• Assisted in management of process deviations and CAPA process.

• Escalated open queries to ensure that all queries are completed in a timely manner.

• Updated and maintained internal databases and tracking systems with project specific information.

• Contributed to the development of Site Management Plans and other related SOPs.

• Assisted with SAE reconciliation as needed.

• Performed case processing activities including adverse event extraction, narrative preparation.

• Performed initial assessment to determine if the case meets criteria for adverse event of special interest (AESI).

• Assisted with preparing summaries for safety reports (PADER and DSUR) Regulatory Document Specialist Nov 2016- Feb 2017

• Maintained regulatory binder.

• Reviewed 1572s, clinical protocols, ICF and IRB documents.

• Assisted CRAs with document control and business technologies (RAVE EDC and Merge eClinical)

• Conducted preparatory regulatory document quality checks.

• Performed quality checks as per HIPAA guidelines.

• Regulatory Affairs

• Quality Assurance

• Safety

• Team Management

• Strategic Planning

• Technical Writing

• Business Development

• Time Management

• Clinical research

• CAPA

• Triage

• Reconciliation

• Case processing

• Data Management

• SOP writing

• 21 CFR, ICH

• GCP, GLP, cGMP

• IND, NDA, BLA, eCTD

• 510(k), PMA

• ISO 9001, 13485

• HIPAA

• Post marketing Surveillance

• MS Office Suite

• RAVE EDC

• MS SharePoint

• Mail Merge Pro

Somesh Milind Gupte

Contact: 857-***-**** email: ***************@*****.*** LinkedIn: www.linkedin.com/in/someshgupte

• Assisted Regulatory Manager in preparing Data Correction forms (DCF)

• Reviewed electronic TMF for completeness and performed interim eTMF exports.

• Coordinated with operations team to update CTMS. Vithai Pharmaceuticals Pvt. Ltd – Mumbai, India Jul 2014 to Aug 2015 QA/RA Associate

Regulatory

• Acted as a liaison and maintained communication with FDA India.

• Ensured compliance while working cross functionally with raw material manufacturers, suppliers and local regulatory agency.

• Assisted in preparing dossiers in CTD format for marketing approval in Sierra Leone, Angola and Ghana.

• Coordinated internally and with involved parties for dossier compilation and query phase.

• Supported and participated in FDA inspections and vendor/ client audits.

Quality Assurance

• Developed, implemented and revised QMS and MSP in accordance with GLP requirements.

• Initiated, implemented and monitored Standard Operating Procedures in compliance with cGMP requirement.

• Reviewed BMR, BCR, COA’s for their accuracy and completion and performed floor inspections.

• Designed QC Specifications of raw materials, packaging materials, intermediates and finished products.

• Performed equipment qualification and validation activities (Product and Process).

• Drafted deviation reports of non-conforming materials and products.

• Initiated and implemented CAPA as required.

Vithai Pharmaceuticals Pvt Ltd – Mumbai, India Jun 2013-Jul 2013 Intern

• Analyzed packaging and performed QC tests on finished products.

• Reviewed and completed Batch Manufacturing Records.

• Reviewed SMF, VMP and COAs.

• Assisted in the manufacturing of liquid orals and dispensing of raw materials. Pharmaceutical Products of India Ltd – Mumbai, India May 2013-Jun 2013 Summer Intern

• Performed Quality control tests (Dissolution tests, UV analysis) on tablets, capsules and powders.

• Reviewed production batch sheets for completeness.

• Assisted in the production of tablets, powders and coated tablets.

• Performed monthly reconciliation of raw materials, packaging materials and finished goods. Graduate Experience

Experiential Learning Network

BBCR Consulting May 2016-Sep 2016

• Analyzed regulatory requirements for US and EU medical devices

• Presented submission pathways and requirements (legislative, clinical, non clinical and post marketing) Flextra Power Mar 2016-May 2016

• Drafted regulatory strategy for nanotechnology smart fabrics.

• Researched regulatory requirements for temperature sensing devices, HIPAA requirements.

• Reviewed any existing marketing statements on the reference products. Leadership

Indian Pharmaceutical Association- Students Forum- Maharashtra State Branch– Mumbai, India Vice chairman (2013-14) Joint General Secretary (2012-13) Public Relations Officer (2011-12)

• Led a team of 150 students to successfully organize the annual pharmacy festival (2000 student participation) University of Mumbai

Student Manager

• Managed 30 students for a social survey of women’s status and population education.

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