JOSY JOS CHERIAN
Centreville,VA
Summary
Project Management and Regulatory Affairs professional with over 10 years of progressive experience leading enterprise IT projects, regulatory compliance initiatives, business process improvements, and cross-functional teams within the U.S. Food and Drug Administration (FDA) and healthcare organizations. Proven expertise managing, Agile project delivery, acquisition planning, stakeholder engagement, regulatory policy implementation, and technical documentation.
Overview
19
19
years of professional experience
Work History
Regulatory Counsel
Food and Drug Administration
Silver Spring, MD
04.2018 - Current
- Managed cross-functional IT projects supporting regulatory submission systems by coordinating with program offices, stakeholders, contractors, and technical teams throughout the project lifecycle, including planning, budgeting, requirements gathering, system design, development, testing, implementation, and post-deployment support.
- Played a key role in the successful implementation of major enterprise applications, including the Tobacco Registration and Listing (NextGen) Module and the Vape Inspection Application, enabling efficient electronic submission processing, inspection management, post-inspection activities, and regulatory compliance oversight.
- Collaborated with Contracting Officer's Representatives (CORs), acquisitions personnel, and program offices to develop Statements of Work (SOWs), evaluate acquisition packages, review contractor deliverables, and ensure task orders were completed on schedule and in accordance with contractual requirements.
- Led operational support for multiple regulatory applications by coordinating enhancement requests, defect resolution, release planning, change management, and system improvements.
- Presented technical and program information to senior leadership, division directors, project teams, and cross-functional stakeholders, translating complex technical concepts into clear business recommendations and project updates.
- Drafted, reviewed, and maintained acquisition documents, Project Approval Guides (PAGs), user guides, job aids, standard operating procedures (SOPs), and other technical documentation to support system implementation and operational consistency.
- Facilitated Agile project management activities, including backlog grooming, sprint planning, user acceptance testing (UAT), release planning, and stakeholder demonstrations to ensure successful delivery of system enhancements.
- Reviewed and provided regulatory recommendations on Warning Letters issued to tobacco retailers, ensuring legal and regulatory sufficiency, consistency with FDA enforcement policies, and compliance with applicable statutes, regulations, and agency guidance prior to final issuance.
- Grade: 13
- Hours per week: 40
Consumer Safety Officer
Food and Drug Administration
Silver spring, MD
04.2016 - 04.2018
- Conducted regulatory reviews supporting the Division of Promotion, Advertising, and Labeling Compliance (DPAL) by evaluating tobacco cigar warning plans, free sample investigation memoranda, complaints, inquiries, and other compliance casework, and prepared briefing materials and recommendations for leadership.
- Conducted legal research and participated in the initiation and implementation of new policies and procedures and provide accurate responses to industry personnel when Deeming rule went final.
- Reviewed and analyzed program policies & protocols and provided guidance on program functions and activities.
- Hours per week: 40
Business Process Analyst
Acenifo Solutions
Reston, VA
05.2015 - 03.2016
- The CDP system is a web-based data entry and reporting system that provides a data repository for Substance Abuse and Mental Health Services Administration (SAMHSA) which leads to improved mental health prevention and treatment services for all Americans. As a Business Analyst, I participated in Client meetings to gather requirements, analyze pertinent data in order to complete documentation.
- Facilitated and coordinated the work of multiple project teams engaged in the establishment and implementation of new projects to support the Project Manager
- Responsible for Requirement gathering, Business Process flow, Business Process Modeling and Business Analysis with Document and Records Management.
- Interacted with the project team to define system objectives and scope, identified constraints and the measures of success for the system to be developed.
- Interfaced with developers to ensure that they clearly understood the requirement and the requirement complies with the customer specifications.
- Participated in daily Scrum and Retrospective meetings to evaluate and address the current status of pending and future impediments.
- Hours per week: 40
Lead Medical laboratory technologist
Quest Diagnostics
Chantilly, VA
10.2007 - 04.2014
- Evaluated, analyzed & addressed various cases during the Avian Flu Outbreak which impacted tens of thousands of individuals. Identified the pattern strains of the virus through research, and disseminated this information to federal and local health officials.
- Wrote justifications to support analytical findings of scientific data.
- Referred to existing laws, regulations and available guidance in order to evaluate scientific data related to medical products.
- Lead the team and served as technical specialist in the areas of biological sciences such as Microbiology and Molecular Biology, and reviewed complex scientific information and provided guidance to non-scientist personnel.
- Communicated scientific and technical information both verbally and in writing to federal, local and state agencies.
- Performed nucleic acid testing of HIV-1, HBV, HCV and West Nile Virus using direct tube sampling systems and robotic sample processors, and conducted serological immunoassay testing of HIV, HTLV, HBsAg, and HCV utilizing robotic sample processors and provided to various
- Ensured that collected data was accurately reflected in the information provided and conclusions reached are supported by the corresponding data.
- Assisted with the structuring & development of sop's regarding newly developed assays, and I possess a significant knowledge of chemical, biological and mathematical principles including laboratory instrumentation, and methodology of different molecular assays.
- Developed new initiatives, guidelines and introduced strategies to support the safety of medical products
- Hours per week: 40
Education
Master's degree - Project Management
George Washington University
washington D.C, VA02-2020
Master's degree - Cell Biology and Molecular Genetics
Long Island University
Brooklyn, NY05-2006
Master's degree - Microbiology
Marathwada University
India05-1997
Bachelor's degree - Microbiology
Madras University
India05-1995
Job-related training
- Certified Scrum Product Owner
- Federal Appropriations Law Class
- Project management training
- New York State certified Clinical Laboratory Technologist
Timeline
Regulatory Counsel
Food and Drug Administration
04.2018 - Current
Consumer Safety Officer
Food and Drug Administration
04.2016 - 04.2018
Business Process Analyst
Acenifo Solutions
05.2015 - 03.2016
Lead Medical laboratory technologist
Quest Diagnostics
10.2007 - 04.2014
Master's degree - Project Management
George Washington University
Master's degree - Cell Biology and Molecular Genetics
Long Island University
Master's degree - Microbiology
Marathwada University
Bachelor's degree - Microbiology
Madras University