Charles Henry
West Chester,PA
Summary
Experienced and decisive leader with a track record of making authoritative business decisions and delivering tangible results. Demonstrated expertise in US and Global CMC Regulatory Affairs/Project Management, with over 20 years of hands-on experience. Skilled in setting product development strategies, devising tactics to achieve goals, and effectively representing clients to regulatory bodies and governmental agencies. Proven project management abilities, including analysis of project objectives, development of schedules, tracking of outstanding items, cross-department coordination, and implementation of necessary quality assurance measures. Adaptable to changing business priorities and adept at managing competing demands efficiently.
Overview
2026
2026
years of professional experience
Work History
President Regulatory Affairs – CMC
CRH Consulting
West Chester, PA
09.2015 - Current
- Formulate and execute strategic initiatives to improve product development and research at Research 1 and 2 Universities
- Facilitate client interactions with the FDA
- Lead regulatory compliance for drug discovery and development in animal studies
- Devise and present business plans and forecasts to the board of directors and investors
Senior Scientist, Regulatory Chemistry Manufacturing and Controls
Cardinal Health, Inc
West Chester, Pennsylvania
08.2019 - 12.2023
- Supervised 5 CMC strategists, enhancing client scientific outcomes
- Implemented documentation strategies for FDA and global submissions
- Managed intellectual property, monitoring client landscapes effectively
- Resolved CMC Regulatory and QA issues, ensuring compliance
- Led 12 strategic API transfers, aligning with FDA and global standards
- Anticipated and identified alternative solutions for the transfer of analytical methods
- Fostered cross-functional partnerships, aligning CMC teams with broader organizational goals to drive comprehensive regulatory compliance and operational efficiency
- Championed interdisciplinary collaboration across departments, fostering innovation and creative problem-solving among colleagues.
Manager Regulatory Affairs - CMC
Virtus Pharmaceuticals, LLC
05.2017 - 11.2018
- Led the day-to-day operations for regulatory affairs by managing internal individual contributors and third-party vendors for timely project execution
- Managed all aspects of pharmacovigilance, including operations and compliance
- Developed regulatory strategies for Virtus generic product pipeline
- Ensured global labeling was compliant with regional/global regulatory requirements, internal standards, policies, and procedures
- Reviewed and approved SPL and drug listings
- Formatted documentation for eCTD submissions (Modules 1, 2 and 3)
- Orchestrated regulatory affairs operations, managing internal teams and vendors for timely project execution while overseeing pharmacovigilance compliance
- Crafted regulatory strategies for generic product pipeline, critically reviewing and preparing FDA submissions including ANDAs, 505B2s, and supplements
- Accomplished multiple tasks within established timeframes.
Regulatory Project Manager
InVentiv Health at GSK
11.2015 - 03.2017
- Directed global CMC regulatory strategies, ensuring compliance and process optimization
- Managed third-party contracts for CMC components in global regulatory submissions, streamlining production and enhancing efficiency
- Coordinated oncology CTA transfers to Novartis, overseeing 2 Parexel staff and documentation
- Championed a proactive approach to managing emerging regulations, staying ahead of industry trends to better anticipate future requirements.
Senior Associate (Contract)
Teva Pharmaceuticals
03.2015 - 11.2015
- Provided thorough review of product labeling, product distribution reports, analytical procedures, product specifications, manufacturing batch records, in-process specifications, and other technical documents before FDA submission
- Managed approximately 100 CMC change controls in Trackwise and GlobalTrackwise EQMS, maintaining accurate and up-to-date records
- Proofread and edited documents for accuracy and grammar.
Director Clinical Research
Grand View Health
05.2011 - 09.2014
- Led clinical research operations, overseeing budgets, contracts, and trial financing for over 23 clinical trials
- Trained approximately 30 investigators and 4 staff on protocols, enhancing team competence in Phase II-IV studies
- Orchestrated comprehensive clinical research activities, from protocol implementation to data integrity assurance, across various trial phases
- Streamlined study start-up activities and close-out visits, enhancing efficiency in clinical trial management
- Managed study activities, ensuring precise data entry and regulatory compliance
- Prepared IRB documentation, facilitating smooth clinical study protocol approvals
- Drove excellence in clinical trial execution, ensuring adherence to protocols and regulatory standards while optimizing research outcomes and team performance
Principal Regulatory Scientist, CMC
INC Research
Manager Regulatory Affairs, CMC
Premier Research
Education
BS - Biology
State University of New York At Cortland
Cortland, NYSkills
- Scientific writing
- Conflict resolution
- Interpersonal skills
- Team building
- Safety procedures
- Adaptability and flexibility
- Decision-making
- Problem-solving abilities
- Technical consulting
- Clinical drug trials
- Critical thinking
- Data analytics
Timeline
Senior Scientist, Regulatory Chemistry Manufacturing and Controls
Cardinal Health, Inc
08.2019 - 12.2023
Manager Regulatory Affairs - CMC
Virtus Pharmaceuticals, LLC
05.2017 - 11.2018
Regulatory Project Manager
InVentiv Health at GSK
11.2015 - 03.2017
President Regulatory Affairs – CMC
CRH Consulting
09.2015 - Current
Senior Associate (Contract)
Teva Pharmaceuticals
03.2015 - 11.2015
Director Clinical Research
Grand View Health
05.2011 - 09.2014
Principal Regulatory Scientist, CMC
INC Research
Manager Regulatory Affairs, CMC
Premier Research
BS - Biology
State University of New York At Cortland
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