Medical Device Social Media

SIMRAN PRAJAPAT

********.*@*****.***.*** 617-***-**** https://www.linkedin.com/in/simran-prajapat SKILLS

General Skills: Written and Verbal communication, MS Office Suite, Schrödinger Suites, Research, Teamwork, Multitasking, Cross- functional interaction, MS Power point, MS Excel, MS Word, MS Project, MS Visio, Chem-Sketch, Analytical Skills Regulatory Knowledge: Well versed with forms like 1571, 1572, 356h, 482, 483, 484, IDE, ICH Guidelines, Regulatory Guidance, Common Technical Document Preparation for INDs, NDAs, ANDAs, BLAs, Gap Analysis, Inspection, Audit, Compliance, Gap assessment, cGMP, cGLP, CAPA, Pharmacovigilance, STED, CTA, BLA, eCTD and NDA, EU Medical Device regulations and standards Regulatory compliance knowledge of FDA IVD requirements, familiarity with QSR device design control process and understanding of IDE application and PMA documents to FDA CDRH Regulatory Standards: 21 CFR Part 11, Part 300-399, Part600-699, Part 800-850, CMC, CTA, knowledge of ISO 13485, IEC 60601, IEC 62304, IEC 62366, ISO 14971, ISO 10993, EU MDD/MDR and QMS, corrective actions and effectiveness checks, BOM Understanding of HIPAA and importance of patient data privacy Publishing Standard: Internal and External publishing standards for US, EU, and Canadian Submissions (via ESG Gateway) WORK EXPERIENCE

RAC Medical Consulting, San Francisco CA May 2020 - Present Quality and Regulatory Associate

• Assisted in the development of regulatory pathways for OTC drugs and cosmetic products with consideration to strategic opportunities, optimal pipeline, lifecycle management and responsible for the interaction with CDER

• Currently providing guidance and support for regulatory framework on combination drug/device delivery system

• Responsible for providing international (EU MDR) and domestic regulatory input to the development of product launch strategy, including documenting testing requirements, submission pathways, and anticipated approval/clearance timelines for defined target markets Innovative Regulatory Science Group (Capstone Project), Boston MA Jan 2020 - Apr 2020 Regulatory CMC Intern

• Foster drug development process by identification and resolution of scientific, regulatory issues and worked on CMC technical documents

• Created timelines in coordination with regulatory submission and accomplished 20-page regulatory strategies to move a compound to Phase I- III

• Managed regulatory CMC activities and submissions with proper ICH guidelines and maintained quality review of Trial Master File (TMF)

• Performed quality control review of documents and work as per GxP standards (GCP, GMP, GLP, GDP) Freyr Solutions, Princeton NJ Apr 2019 - Sep 2019

Regulatory Affairs Intern

• Performed with DLP, SLP, RLP, File Tagging, Leaf Title Modifications, Bookmarking, Hyperlinking and QC on regulatory documents

• Managed compilation and maintenance of documentation such as Clinical Study Reports, SUSAR, DSUR and Life Cycle Management

• Collaborated with fellow interns to review modules using eCTD Tools like Liquent IP, Freyr submit pro, LORENZ Docubridge and built various submissions within eCTDXPress for NDA and IND applications (Veeva vault, CREDO) which lead to US FDA approval

• Streamlined process of electronic IND and BLA submissions including Annual Report, Protocol Amendments, PADER/PBER, Information amendments, IND safety Reports, Meeting Request, Prior Approval Supplement, REMS, Labelling Supplements, Investigator Brochures (IBs) submitted to the FDA

• Customized the preparation of premarket or other regulatory applications (510(k), PMA, STED, Technical Dossiers, etc.) for a combination product by attending team meetings and provided pertinent updates and regulatory overview to supervision

• Worked on regulatory tool to smoothen analysis of Cosmetic and Food ingredients used in various global regulated markets Mylan Laboratories Limited, Pithampur, India Jun 2017 - Nov 2017 Regulatory and Quality affairs Intern

• Assisted in the preparation of revised SPLs for ANDAs, NDAs and BLAs throughout product life cycle

• Maintain current knowledge of FDA regulations and guidance’s pertaining to labeling, SPL, and registration by utilizing the FDA website, attendance of conferences and attendance of SPL working group conference calls INDUSTRY PROJECTS

CannJoin Innovation and Enterprise Inc. Boston MA Jan 2019 - Jun 2019 Regulatory Project Assistant

• Researched Cannabis regulations to construct user rules and guidelines for social media platforms and privacy policy, to recommend usage

• Implemented review and approval of Product Labelling, Promotional, and Advertising Materials to ensure regulatory compliance

• Established a comprehensive education curriculum and licensing framework for cultivation, home-growth, and disposal of Cannabis by considering regulations for cannabis growing and disposal in New York and California

• Created a business model comprising of cost estimation, educational curriculum, public concerns, advertising of licensing plan Lyndra Therapeutics (Regulatory Project Intern), Boston MA Sep 2018 - Dec 2018 Regulatory Strategy Intern

• Gathered US regulatory intelligence pertaining to opioid use disorder, controlled/extended release dosage forms, GI tract delivery technologies and potential challenges that developers/applicants experience in progressing these forms through registration and approval

• Acknowledged regulatory building blocks for multi-molecule portfolio, primarily established API's (approved for use in humans)

• Ensure assigned CMC regulatory submissions aligns with regulatory strategy and proactively work with teams to identify gaps or mitigation plans EDUCATION

Northeastern University, Boston, MA GPA: 3.62

Master of Science in Regulatory affairs for Drugs, Biologics and Medical device Jan 2018 – Jun 2020 Govind ram Seksaria Institute of Technology and Science, Indore, India GPA: 3.5 Bachelor of Pharmacy May 2017

ACADEMIC PROJECTS

Northeastern University Boston, MA Apr 2018 - Aug 2019

• Prepared IND Applications, NDA, 510(k) for a medical device (I-Factor peptide enhanced bone graft)

• Developed a regulatory strategy for Class II (510k submission) medical device (ELISA TEST KIT) into different regulatory market

• Drafted an annual report and a new protocol to an open IND and devised a Pre IND meeting with the FDA for the New Drug Development

• Composed promotional material to OPDP for advisory comments and reviewed FDA enforcement letter with promotional materials

• Drafted Informed Consent Forms (ICFs) and completed IRB application for clinical trials

• Developed CAPA and SOPs for eCTD IND Submissions

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