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Hi, I’m
HIREN PATEL
Regulatory Affairs Specialist
Hicksville,NY
Summary
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.
Overview
2
years of professional experience
Work History
Ascent Pharmaceuticals, Inc.Central Islip, NY
Regulatory Affairs Specialist
06.2022 - Current
Job overview
- Prepared and submitted regulatory file applications and supporting documentation.
- Maintained and archived regulatory paperwork.
- Received, researched and resolved consumer inquiries.
- Experience independently authoring, compiling, and reviewing ANDAs, DMF, Amendments, Supplements, Annual Reports and Periodic Adverse Drug Experience Report (PADER) for submissions
- Using ROSETTA Phoenix™ and pharmaREADY® compile ANDA documents into eCTD fomat.
- Interact with Research & Development, Quality Assurance/Quality Control (QA/QC), and Production for gathering data and documentation for submissions
- Review and audit data submitted by technical departments (R&D, QA/QC) and outside firms
- Assist in developing draft labeling for proposed and existing drug products
PNI TherapeuticsBoston, MA
Regulatory Affairs Intern
01.2022 - 04.2022
Job overview
- Medical device regulations, including 510k filings, are familiarized with by the FDA and ISO
- The position will work closely with the R&D/Engineering group as well as QA/RA
- Regulatory filings for Class I thru Class III medical devices
- Conduct Regulatory impact assessment for changes to design, labeling, process and engineering specifics for medical devices and assist in development of 510(k) submissions.
Harshiddh Medical StoreMehsana, Gujarat
Pharmacist Assistant
08.2018 - 04.2019
Job overview
- Communicated instructions to patients or caregivers about proper use and storage of drugs
- Assisted pharmacist by filling prescriptions for customers and responding to patient questions regarding prescription and medication-specific issues.
- Manages daily drug inventories and accurate end of month inventory.
- Checks all orders for completeness of information. Verifies patient information and proper physician authorization.
Vimson AerosolAnand, India
Quality Control Trainee
05.2016 - 06.2016
Job overview
- Gained practical knowledge Labeling, and Storage to build understanding how pharmaceutical industry worked.
- Maintained complete, accurate, and legible test records, reviewing data for accuracy and trends, and communicating concerns to the supervisor
- Assist QC Manager with maintenance of inventory, retain samples, reference standards.
Education
Anand Pharmacy College
Bachelor of Science from Pharmacy
Northeastern University
Master of Science from Regulatory Affairs
Skills
Forms management, Technical Documentation
Virtify eCTD
Risk management
Good organizational and time management skills; ability to adhere to timelines
Very strong attention to detail
Software
Pharma Ready
Pragmatic Validator
Adobe illustrator
Microsoft Office
Timeline
Regulatory Affairs Specialist
Ascent Pharmaceuticals, Inc.
06.2022 - Current
Regulatory Affairs Intern
PNI Therapeutics
01.2022 - 04.2022
Pharmacist Assistant
Harshiddh Medical Store
08.2018 - 04.2019
Quality Control Trainee
Vimson Aerosol
05.2016 - 06.2016
Anand Pharmacy College
Bachelor of Science from Pharmacy
06.2018
Northeastern University
Master of Science from Regulatory Affairs
04.2022