Contact: +1-847-***-**** Meet Hitendrabhai Patel Email: adi4tz@r.postjobfree.com

Boston, MA

Professional Summary

A self-motivated experience professional having sense of responsibility, learnability and adaptability who can deliver expected results within given time frame as an individual and also as a key team member with excellent coordination and sound decision making.

Qualification

Master of Science in Project Management Sep 2019 – Dec 2020 Northeastern University, Boston, MA, US. GPA: 3.6

Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices April 2016 – May 2018 Northeastern University, Boston, MA, US. GPA: 3.7

Bachelor of Pharmaceutical Sciences Aug 2010 – May 2014 Gujarat Technology University, Gujarat, India. GPA: 6.54 Skills

• Well versed with IND, NDA, BLA, PMA, IDE, 510(k) Submissions.

• Well versed with FDA Forms: 1571, 1572, 3674, 3454, 3455, 3500, 3500A, 3962, 483, Warning Letters and Type A, B, (Pre-IND &EOP 2), & C meetings.

• Possess a thorough understanding and implementation of ISO 13485, ISO9001, ISO62304, and ISO14971

• Well versed with medical devices regulations and development De Novo Submissions, Humanitarian Device, Exemption, Quality System Regulations 21CFR 820, CAPA, Post Marketing Activities and Post Market Surveillance Studies.

• Regulatory knowledge of Drug Development Process including ANDA, Orphan Medicinal Product Designation, CMC Guidelines, CGMP Regulations for Drug: 21CFR 210 and 211, Regulations and Policies associated with Drug Post Marketing Activities. Professional Experience

Medical Business Associate at Glaxo Smith Kline Plc. Gujarat, India (July 2018- Jun 2019)

• Collaborated with Area Business Manager of the assigned territory to map current prescribing patterns of local respiratory disease KOLs to understand trends in use of anti-bacterial therapies

• Optimized messaging and customer engagement strategy to explain value of Augmentin and complimentary therapies in GSK portfolio, leading to increase in key account sales by more than 15%

• Liaised with local medical team to conduct educational events to highlight clinical benefits of Augmentin over existing standard of care like Cephalosporin’s

• Analyzed primary and secondary sales data from local distributors, stockiest and pharmacists, to understand the trends in local usage of four key portfolio drivers- Augmentin, Neosporin, Calpol and Zintac. QA Specialist at Acme Pharmaceutical PVT.LTD. Gujarat, India. (May 2014- March 2016)

• Drafting, revising and reviewing GMP quality documents like Batch Production records, SOPs, Master Formula Records, CMC sections of regulatory filing, logbooks, annual product Quality reports, validation/qualification protocols and reports as per Good Documentation practices.

• Supervising in process quality checks of ongoing commercial production and involved in carrying out internal quality audits.

• Handling Quality non-conformance issues i.e. incidents, deviations and change requests; Root cause analysis, suggestion and implementation of CAPAs.

• Reviewed local cGMP guidance documents and mapped it against current manufacturing practices to ensure compliance to local standards.

Academic Project

• Drafted Informed consent form and clinical Protocol for drug indicated for Diabetic Neuropathy

• Drafted documents and filed IND application to hypothetical to FDA for drug indicated for Diabetic Neuropathy

• Developed a 510(K) submission for Pacemaker indicated for Symptomatic Bradycardia.

• Developed a regulatory submission of Blenrep in common technical document format. (NDA Application)