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Medical Device Manufacturing

Boston, Massachusetts, United States
February 12, 2018

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** ***** ********* **., ******, MA *2120 M: +1 (857) ***-**** E: LinkedIn:


Northeastern University, Boston Expected Fall 2018 Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices GPA: Current 3.3 Course Modules: Introduction to Drug and Medical Device Regulation, New Drug Development: Regulatory Overview, Medical Device Development, Biologics Development, Human Experimentation, Asian, Latin American, Canadian regulatory affairs. Institute of Pharmacy, Nirma University, Ahmedabad, India Aug 2012 - May 2016 Bachelor of Pharmacy (B.Pharm) CGPA: 7.89


Quality Assurance Intern, Swiss Parenterals Ltd., Ahmedabad, India June 2015 - August 2016

• Worked efficiently in the manufacturing unit by complying with Good Manufacturing Practices (GMP), good laboratory practices (GLP), good clinical practices (GCP)

• Experienced with the managerial responsibilities regarding arrangements for manufacturing, supplying, and use of correct starting materials and packaging as well as documenting standard operating procedures (SOPs) for the equipment.

• Assigned with the duties of controlling the starting materials, intermediate products, finished products and other in-process controls, calibration, validation for the processing and checking its quality. SKILLS

• Regulatory skills: Regulations Governing Clinical Trials, FDA, HHS, ICH guidelines, Clinical Trials Agreements, Material Transfer Agreements, pre-clinical drug development, Asian, Canadian, Latin American regulatory affairs, NDA, IND, Regulatory Issues Impacting Clinical Trials After IRB approval, BLA, Biosimilars, 510(K) submission, PMA, PMA Supplements, Combination product, MDR event, QSR, IDE, IVD, CMC, GCP, GLP, GMP, Informed Consent, ICF, IRB requirements, Process of Clinical Trials, Right of Access to Investigational Drugs and Devices, Marketing Exclusivity & IP Considerations for Biologics, PDUFA initiative. PROJECTS AND ACHEIVEMENTS

• Analysis of Sandoz’s Omnitrope approval under 505 (b) (2) of the FD&C Act Developed familiarity with FDA website, learned about the regulatory milestones of the approval of the product, regulation of the product by CBER, researched about the pre-clinical safety data provided to CBER, learned about the IND, clinical and investigational plan of the product.

• Medical Device Submission: Regulatory Strategy for: 1) Tridyne Vascular Sealant 2) Restylane Refyne, Restylane Defyne Developed a regulatory strategy for the above devices including device description (PMA number, product code, classification of the device), labelling information, pre-clinical and clinical studies, financial disclosures, post marketing recommendations, conditions on approval, PMA supplements and its approval.

• Analysis of the Biologics Price Competition and Innovation Act: Amgen v. Sandoz/ Genentech v. Amgen biosimilar litigation.

Worked upon the policies of biosimilar litigation, analysis of both the parties over the dispute of patent dance subject of BPCIA, arguments of both the companies over the biosimilar litigation and its impact on public health.

• Thesis on “Pharmacological Analysis of Nardostachys jatamansi in ADHD and Alzheimer’s disease. Research based documentation of the overview of the diseases, pharmacology of both diseases, pharmacognosy, plant profile, structure and chemistry of N. jatamansi, molecular targets in the brain for both the diseases, molecular docking, stages of docking, identified possible targets and constituents for curing both the diseases.

• Strategic planning and project management for approval of class III medical device in Canada, Europe, Latin America.

Prepared regulatory strategy as per requirements of respective countries, breaking up budget allocation for: setting up manufacturing sites, language translation, choosing legal manufacturer at the manufacturing site, consultancy fees, etc.

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