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Quality Medical

Wilmington, MA
September 19, 2018

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ASTHA D. THAKER 857-***-**** 75, Saint Alphonsus Street, Boston, MA, 02120 EDUCATION

Northeastern University, Boston MA Sept 2016-July 2018 Master of Science in Regulatory Affairs in Drugs, Biologics and Medical Devices. Nirma University, Institute of Pharmacy, India August 2012- May 2016 Bachelor of Sciences in Pharmacy


Experiential Learning Program with Englewood Lab, NJ April 2018-July 2018

Led a team of 3 in a project management plan for the development of a novel molecule from phase II to its approval.

Created Gantt charts, stakeholder analysis, risk analysis and response strategies.

Determined the CMC from the structure of molecule and crafted an investigator’s brochure for study.

Designed clinical study for the drug, requested a type B meeting with FDA for a breakthrough therapy of approval and submitted the results by eCTD format.

Provided a regulatory strategy for distribution of drug in US, EU, China and Japan. Post-Market Surveillance Specialist, Medtronic, Mansfield, MA Sept 2017-April 2018

Evaluated incoming complaints of Class II and III medical devices and maintained a regulatory database (GCH) for it.

Analyzed International report ability (MDR/AE) of complaints to FDA.

Documented the conclusions from the investigation on to the company’s electronic database.

Monitored quality, completeness and timeliness of complaint investigations and files.

Drafted Regulatory reporting of adverse events caused by the surgical devices as per 21 CFR 803.

Submitting Medwatch MDR 3500A forms to the FDA.

Generated CRLs (Customer Response Letters), which includes informing the customers about the functional and visual results of the investigation performed on the product they returned.

Communicated with customers and sales representatives to respond to complaint reports.

Led a team of 3 by managing the distribution of daily WIP given by higher management. Regulatory Intern at Biocare Remedies Pvt Ltd., Ahmedabad, India May-July 2015

Generated and maintained documentation such as works instructions, Standard operating procedures (SOPs).

Reviewed incoming SOPs for regulatory compliance and was responsible for follow up with concerned team.

Handled UV Spectrophotometer, HPLC, Tablet punching, Sterilization, centrifugation.

Deliver quality regulatory submissions.

QA/QC Intern at Biocare Remedies Pvt Ltd., Ahmedabad, India May-July 2014

Performed quality control tests like disintegration, dissolution, hardness etc. to ensure the quality of the product.

Worked as quality assurance assistant to ensure the validation of products.

Assisted with product manufacturing, labeling and packaging of oral liquids, tablets capsules, lycopene capsules, dry syrups and injections, ointments, granules etc.


Documentation skills:

Have thorough knowledge of 510k, SOPs, CMC, Clinical Trial Application (CTA), eCTD, Clinical Protocols, IND, BLA, NDA. Pharmacy tools and skills:

Tablet punching machine, UV/VIS Spectrometer, Gas Chromatography, Osmolality, Chemical synthesis, Regulatory Submissions, Regulatory writing, Quality system management, Quality system regulations. Computer skills:

MS Outlook, MS excel, MS Word, MS PowerPoint, Medchem draw, Accelrys Draw 4.1, Chem draw. Academic Projects Northeastern University

Submitted PMA and created regulatory strategy for Trydyne Vascular sealant including the IDE.

Developed a regulatory plan for the approval of the combination product Restylane Refyne and Restylane defyne and the discovered the Prescription as per MDUFMA Act.

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