Medical Device Project

Unnati Bhuptani

San Jose, CA, ***** ******.********@*****.*** https://www.linkedin.com/in/unnati-bhuptani/

Experience:

GlaxoSmithKline Vaccines, Rockville, MD July 2017 – April 2018 Regulatory Affairs Associate (Business Student Worker)

• Performed IND maintenance activities by ensuring timely submissions of US regulatory submissions such as Response to the FDA IR’s, DSUR’s, updated Investigator Brochure, CMC Amendments in coordination with global teams

• Facilitated submissions by notifying publishing and reg ops team, completing forms 1571 and 3674, initiating the line management review and final review of the documents

• Created cover letters with clarity and detail for US Regulatory submissions and place them in the Documentum

• Adapted quickly to the new internal archiving system and assisted in the development and revision of standard processes for this activity

• Developed a global template for Briefing Document for regulatory agencies of US and EU

• Developed and updated the Standard Operating Procedure (SOP) templates for regulatory submissions such as IND

• Proactively performed Project Management Activities for internal regulatory meetings

• Provided regulatory support in change control meetings, core team submission and regulatory strategy meetings

• Researched applicable regulatory requirements, updated guidance and regulations using internal and external websites and databases

MediaMedic Communications, Mumbai, India May 2016 – June 2016 Intern

• Researched about the product and the applicable regulations to create advertisement and promotional materials for healthcare products in US and European markets

BLISS GVS LTD, Palghar, India May 2015 – June 2016 Pharmaceutical Trainee / Intern

• Performed SOP review, GAP analysis and IPQC tests such as weight variation, hardness, thickness, disintegration, calibration of the weighing balance and pH meter

• Trained on Good Manufacturing Practices, Good Documentation Practices, IPQC and Quality Assurance Education:

Northeastern University, Boston, MA July 2018

Master of Regulatory Affairs for Drugs, Biologics and Medical Devices GPA: 3.8/4.0 Related Coursework: Regulatory Overview: Medical Device Development, Global Biotech Product Registration: E.U., U.S., Japan, Latin America, EU Compliance, Canada, Asia & Latin America Regulations, Regulatory Documentation Processes Academic Project:

• Capstone Project: Worked with a medical device employer to design a strategy to obtain regulatory approval along with market analysis in Australia, NZ, and India for their product. Devised a regulatory strategy by analyzing the three markets, identifying the classification of the product and mapping out the regulatory hurdles likely to be faced by the company

• Regulatory Pathway: Researched and interpreted the US medical device regulations to apply them to a Class III vascular sealant. Developed strategic skills by designing a regulatory pathway for the device TRIDYNETM which is a class III device

• Regulatory Approval Review: Proposed the creative solutions to eliminate the deficiencies in the BLA for a marketed product Cosentyx by reviewing the deficiencies which delayed the regulatory approval Dr. Bhanuben Nanavati College of Pharmacy, Mumbai, India May 2016 Bachelor of Pharmacy (B. Pharm) GPA: 6.8/10

• Certification: Drug Regulatory Affairs

Technical Skills:

• Regulatory submissions: IND, NDA, BLA, ANDA, 510(k)s, PMA, PMA supplements, HDE, IDEs, Meeting Request letters, Briefing Documents, Informed consent, Clinical Protocol, CMC Amendments, Centralized and Non-Centralized procedure

• Regulatory Guidelines: QSR, Risk Management, ICH guidelines, GMP, GLP, GCP, EU MDD, EU MDR, Packaging and Labeling requirements, 21 CFR 820, 21 CFR 312 and 314, 21 CFR 600-660, 21 CFR 200-800, ISO guidelines, FDA guidance documents

• Regulatory Agencies: U.S.FDA, EC, EMA, PMDA, MHLW, Health Canada, CDSCO

• Computer Skills: Documentum, eCTD viewer, MS Office Suite including MS Word, MS Excel, MS PowerPoint, MS Publisher, MS Outlook, Adobe Acrobat, data analysis, Tally 9.2, Java (basic), C (basic), SharePoint

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