Charles Henry
West Chester,PA
Summary
Dynamic leader and Senior Scientist from Cardinal Health, Inc., with over 20 years of expertise in US and Global CMC Regulatory Affairs and Project Management. Excelled in driving strategic FDA submissions and global compliance, leveraging strong project management and scientific writing skills. Proven track record in fostering cross-functional partnerships and enhancing scientific outcomes through innovative solutions.
Overview
13
13
years of professional experience
Work History
Senior Scientist, Regulatory Chemistry Manufacturing and Controls
Cardinal Health, Inc
West Chester, PA
08.2019 - 12.2023
- Supervised 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 strategic API transfers, aligning with FDA and global standards
- Anticipated and identify 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
President Regulatory Affairs – CMC
CRH Consulting
West Chester, PA
09.2015 - 08.2019
- Aligned strategic development for government departments, enhancing product initiatives
- Developed regulatory tactics, facilitating client interactions with FDA and global agencies
- Established comprehensive filing plans for global Clinical Trial Applications, ensuring compliance
- Led regulatory strategy development for global clinical trials, collaborating with FDA and international agencies to ensure compliance and streamline product approvals
Manager Regulatory Affairs - CMC
Virtus Pharmaceuticals, LLC
Langhorne, PA
05.2017 - 11.2018
- Company Overview: (Acertis Pharmaceuticals)
- Led the day-to-day operations for regulatory affairs by managing internal individual contributors and third-party vendors to for timely project execution
- Managed all aspects of pharmacovigilance, including operations and compliance
- Developed regulatory strategies for Virtus generic product pipeline
- Assured 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
- (Acertis Pharmaceuticals)
Regulatory Project Manager
InVentiv Health at GSK
Upper Providence, PA
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 Parexel staff and documentation
Senior Associate (Contract)
Teva Pharmaceuticals
Horsham, PA
03.2015 - 11.2015
- Provided a thorough review of product labeling, product distribution reports, analytical procedures, product specifications, manufacturing batch records, in-process specifications, and other technical documents prior to FDA submission
- Managed CMC change controls in Trackwise and GlobalTrackwise EQMS, maintaining accurate and up-to-date records
Director Clinical Research
Grand View Health
Sellersville, PA
05.2011 - 09.2014
- Led clinical research operations, overseeing budgets, contracts, and trial financing
- Trained investigators and 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
Manager Regulatory Affairs, CMC
Premier Research
Philadelphia, PA
Principal Regulatory Scientist, CMC
INC Research
New Hope/Horsham, PA
Education
BS - Biology
State University of New York at Cortland
Skills
- Strong leadership skills with proven results in making authoritative business decisions
- Twenty years’ hands-on experience with US and Global CMC Regulatory Affairs/Project Management
- Strong project management skills
- Ability to quickly adapt to changes in business priorities
- Machine learning
- Training and mentoring
- Chemical synthesis
- Application of scientific principles
- Scientific writing
- Cell culture techniques
- Experimental design
- Protein purification
- Safety processes and procedures
- Intellectual property
- Data analytics
- Assay development
- Advanced research techniques
- Project management
- Technology transfer
- Lab experiments and research
- Microscopy expertise
- Statistical modeling
- Bioinformatics analysis
- Drug discovery
- Research management
- Computational modeling
- Research and experiments
- Technical presentations
- Expert data analysis
- Results analysis
Projects
Sklice (ivermectin, 0.5% lotion) Pre-clinical through Phase 3 Diclectin (doxylamine succinate 10mg/Pyridoxine HCl 10mg) FTIH through Phase 2 Zorvolex (nano-particle diclofenac) Phase 2 to Phase 3 Tivorbex (nano-particle indomethacin) Phase 2 to Phase 3 INL-001 (bupivacaine-collagen implant) Phase 2 INL-002 (gentamicin topical) Phase 2 Factor X (BLA) Tecovirimat (ST-246, smallpox) pre-clinical to Phase 3 PZ-601 (carbapenem) Phase 2 DIFICID (fidaxomicin) Pre-clinical to NDA
References
References available upon request.
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 - 08.2019
Senior Associate (Contract)
Teva Pharmaceuticals
03.2015 - 11.2015
Director Clinical Research
Grand View Health
05.2011 - 09.2014
Manager Regulatory Affairs, CMC
Premier Research
Principal Regulatory Scientist, CMC
INC Research
BS - Biology
State University of New York at Cortland
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