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Medical Device Manager

Boston, Massachusetts, United States
April 22, 2019

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Boston, MA 617-***-**** Available: July-Dec 19 A dynamic, enthusiastic, passionate, diligent regulatory affairs graduate student with experience in the manufacturing and R&D department of biopharmaceutical industry. Fascinated in gaining exposure to the regulatory department of the industry. EDUCATION:

Northeastern University, Boston, MA Dec 2020

Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices GPA:3.9/4.0 Related Coursework: Introduction to Drug and Medical Device Regulations, Medical Device Development: A Regulatory Overview, Therapeutic Product Development: A Regulatory Overview, Fundamentals of Clinical Trials Activities: Global Leadership Institute (GLI): Lead 360, NU International Global Pathway, NU Sanskriti: Tarang 2019 Shivaji University, Kolhapur, India May 2017

Bachelor of Biotechnology Engineering GPA:4.0/4.0

Related Coursework: Good Manufacturing Practices (GMP), Bioinformatics, Cell Biology, Immunology, Genetic Engineering Activities/ Honor’s: Shivaji University Merit Scholarship (awarded annually), KIT Pride Award SKILLS AND COMPETENCIES:

Regulatory Competencies:

Comprehensive understanding of ICH guidelines, US FDA Regulations, 21 CFR Part 50, 54, 56, 58, 210, 312, 314, 600, 601

Thorough knowledge of CMC, GMP, GLP, GCP, IND, NDA/ANDA, BLA, ICF, IRB, CAPA, REMS, eCTD, Recalls, Labeling, Packaging, and Marketing requirements, Pharmacovigilance, Warning letter response,

Accustomed to Federal Register, FDA Guidance,, Computer Skills: MS Word, MS PowerPoint, MS Excel, Adobe Creative Suite, ISIS Draw, VlifeMDS, WinCAT PROFESSIONAL EXPERIENCE:

Research Associate, Wockhardt Research Center, Aurangabad, India Dec 2017-June 2018

Developed and optimized downstream process for purification of therapeutic protein to increase purity of API > 99.5%

Performed purification of therapeutic protein by preparatory chromatography methods such as Ion exchange chromatography and Reverse-phase liquid chromatography Summer Intern, Biological E, Hyderabad, India June 2016-Aug 2016

Conducted daily calibration of instruments such as: weighing balances, pH, and conductivity meter

Analyzed different in-process samples by the methods such as: SDS PAGE, micro BCA assay, phenol sulphuric acid assay, and nucleic acid detection, (HPLC, Size Exclusion Chromatography), and western blot Summer Intern, Wockhardt Biotech Park, Aurangabad, India May 2016

Evaluated microbial load by plate method and detected endotoxins by Bacterial Endotoxin Test (BET)

Studied different Good Manufacturing Practices (GMP) such as: change control, deviation, and maintaining SOPs Trainee, BAIF (Bharatiya Agro Industries Foundation), Pune, India Dec 2015-Jan 2016

Monitored and controlled an operation of 350 L fermenter used for Biofertilizer production

Executed soil analysis through Soil Profile Class (SPC), Total Viable Count (TVC), Most Probable Number (MPN) EXPERIENTIAL NETWORK (XN) PROJECT:

Education and Licensing for Cannabis Growing and Disposal, CannJoin, Canada Jan 2019- Mar 2019

Manage a team of four members to perform business analysis of cannabis education and fee collection structure

Develop a comprehensive education curriculum and licensing framework to cultivate, prepare, and dispose of household cannabis


IND and NDA Consulting, Northeastern University, MA Jan 2019- Mar 2019

Applied understanding of course material to provide operational and strategic advice towards submission and maintenance of IND and NDA application to a hypothetical client

Submitted five-page cogent proposals to Justify advice through reference to applicable ICH Guidelines, FDA Guidance documents, and 21 CFR parts Pharmacology Review, Northeastern University, MA Feb 2019

Utilized to prepare a comprehensive overview of the nonclinical program for an FDA-approved product Proposed Rule Evaluation, Northeastern University, MA Jan 2019

Selected a proposed rule from the Federal Register, titled “Definition of the Term Biological Product”

Evaluated and summarized its purpose, and justified an opinion on its potential advantages and drawbacks Informed Consent Form (ICF), Northeastern University, MA Sept 2018- Oct 2018

Designed an ICF for the Phase 2 clinical trial to evaluate the Efficacy and Safety of the drug

Provided clear, comprehensive information about study specifics procedure, enrollment criterion, risks, benefits

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