Ramesh Awal
Hayward,CA
Summary
Seeking for the mid-senior level role in regulatory affairs where career opportunities and professional growth are profound. Professional with experience in regulatory affairs, well-equipped to navigate complex compliance landscapes and drive successful outcomes. Skilled at interpreting regulations, preparing submissions, and managing documentation. Strong focus on team collaboration, adaptability, and achieving results in dynamic environments. Known for effective communication, continuous improvement and problem-solving abilities.
Overview
7
7
years of professional experience
Work History
Regulatory Affairs Specialist
Tosoh Bioscience, Inc.
02.2024 - Current
- Solely responsible for regulatory activities with Health Canada such as MDSAP updates, license amendments, annual reports, and new submissions.
- Assisted the Senior Specialist with Class II predicate comparisons and research to support 510K Submission.
- Facilitated electronic data capture (eDC) for adjudicators by managing subject assignments and maintaining real-time tracking systems.
- Ensured consistency and compliance in product labeling by reviewing and approving label designs and promotional materials.
- Reviewed and updated standard operating procedures periodically, while also generating work instructions and forms as needed.
- Interpreted regulatory rules and changes, conducted impact assessments, and communicated findings with cross-functional teams and the manufacturer’s R&D department.
Regulatory Affairs Associate
Tosoh Bioscience, Inc
02.2019 - 02.2024
- Maintained records of Approvals and Expiry of product licenses
- Coordinated with compliance documents for new product registration, renewal and amendment in Brazil, Canada, Argentina, Colombia and Mexico and other Latin Americas
- Performed Regulatory Assessment for the Change Control whether it needs to notify regulatory agencies or not
- Performed Gap Assessment of Technical documents requirement for ANVISA and Communicating with Manufacturer
- Collaborated with the Sales & Marketing team and appointed distributors in Latin America for new product registration and launch
- Submitted Health Canada Annual Renewal Forms along with reporting non-significant changes in product
- Performed predicate research and literature search to support medical device submission
- Prepared and Submitted PMA Annual report to CDRH/FDA
- Requested export certificates such as Certificate to Foreign Government (CFG) / Certificate of Free Sale (CFS) / Free Sale Certificate (FSC) from different authorities
- Assessed the revised ClSI guidelines and SOR 98-282 regulation to determine the impact on the marketed products or products in development
- Reviewed CRF and addressing Queries
- Involved in developing Clinical Trial eCRF in eDC called 'SMART-TRIAL' by Greenlight Guru, Facilitating weekly meetings with the site for progress, supplies need, and any concerns
Regulatory Affairs/Quality Assurance Intern
Tosoh Bioscience, Inc
06.2018 - 12.2018
- Compiled and maintained regulatory documentation for renewal and new product registration in Canada and LATAM regions
- Recorded and updated license spreadsheet for approved products
- Assisted Regulatory Specialists with Global Unique Device Identification Database (GUDID) project for all marketed products
- Personally handled Apostille and Notarization of the Certificates and Letters
Education
MBA - International Business
Lincoln University
Oakland, CA12.2018
BBA - Marketing
King's College
08.2014
Skills
- Collaboration
- Greenlight guru Clinical
- Team Player
- ANVISA
- SOR 98-282
- 21 CFR
- Product Labeling
- MS Offices
- Mondaycom
- IMDRF
- Building eCRF in eDC System
- Trial Master File
- Proofreading
- Regulatory Documentation
- Clinical Operation
- GMDN
- Gap Assessment
- GUDID database
- Tech File Co-ordination and Maintenance
- eSTAR
- Knowledge Document Management
- Communication
- Adobe Acrobat
- Basic Statistical Analysis
- Techstreet
- Initiative
- Proactive
- FDA Database
- GHTF
- Experience in MS Offices
- Labeling requirements
- Task Prioritization
- Regulatory research
- Continuous Improvement
- Process Improvement
- Documentation Management
- Organizational Skills
- Critical Thinking
- Multitasking ability
- Attention to Detail
- Clinical Trials Oversight
- FDA regulations
- Data Verification
- Labeling and Packaging
- Change Control
- Submission preparation
- Written communication
- Time management abilities
- Goal setting
- Team collaboration
- Multitasking Abilities
- GUDID
- FURLS
Accomplishments
- Worked in several capacities.
- Re-organized the Regulatory Documents.
- Complimented by Sales Dept Colleague.
Offered to take the lead as Clinical Data Manager to build the eDC system and train on the system for internal department and the external parties i.e clinical site, address any day to day operation issues of the eDC System and manage clinical TMF documents.
Organized previously dispatched submission documents and Tech file with proper file and folder naming convention projects which saved time for the company for future reference and the projects.
Successfully completed Health Canada license amendment to include the new product launch in timely manner.
Conferences/ Webinars
- RAPS Workshop: Survivor: The FDA 510(k) Program Edition
- Canada's Regulatory & Quality MedTech Conference 2023, 06/2023
- Regulatory Education for Industry (REdI) Annual Conference 2022-CDER Track, 06/2022
- FDA Pre-Submission - Emergo, 11/2020
- 10 Steps to preparing your 510(k) submission (And How to Avoid the Common Pitfalls)- Greenlight Guru, 08/2019
Certificates/ Courses
- Introduction to Cancer Biology, John Hopkins University, 10/2023
- Medical Device Certificate, RAPS Online University, 01/2020-10/2023
- Clinical Data Management, San Francisco State University, 07/2019-08/2019
Languages
Nepali
Native or Bilingual
English
Professional Working
Hindi
Limited Working
Spanish
Elementary
French
Elementary
Timeline
Regulatory Affairs Specialist
Tosoh Bioscience, Inc.
02.2024 - Current
Regulatory Affairs Associate
Tosoh Bioscience, Inc
02.2019 - 02.2024
Regulatory Affairs/Quality Assurance Intern
Tosoh Bioscience, Inc
06.2018 - 12.2018
BBA - Marketing
King's College
MBA - International Business
Lincoln University
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