Samuel Herald
Global Regulatory Affairs Executive specializing in Strategic Leadership, CMC, and Operations
- Role
- Us Army Reserve Executive Officer at Defense Logistics Agency
- Location
- Smyrna, NY, US
- LinkedIn followers
- 500 followers
About Samuel Herald
Senior Regulatory Affairs executive with 25+ years of progressive experience leading global Chemistry, Manufacturing, and Controls (CMC) strategy across innovative, generic, biologic, and OTC pharmaceutical products. Proven leader with deep expertise in global regulatory submissions, Health Authority engagement, lifecycle management, and regulatory modernization. Demonstrated success building and managing high-performing global teams, driving operational excellence, and delivering value-based regulatory solutions for top-tier pharmaceutical clients. Trusted advisor to executive leadership with a strong record of navigating complex regulatory environments, implementing standardized processes, and enabling successful NDA, BLA, ANDA, and post-approval outcomes.
Experience
Us Army Reserve Executive Officer
Jul 2023 — Present · New Cumberland, PA, US
Provides logistical support, personnel management, training oversight, and directly interfaces with DLA personnel and customers. Prepare comprehensive joint logistics and staffing plan in the event of activation or mobilization for both emergency and non-emergency events. Develop training plans for soldiers in my unit, evaluate performance, and ensure soldier well-being
Education
Slippery Rock University
Bachelor of Science - BS, Environmental Science
Temple University
Master of Science - MS, Quality Assurance and Regulatory Affairs
Skills
- Regulatory Affairs
- Pharmaceutical Industry
- Fda
- Gmp
- Sop
- Biotechnology
- Regulatory Submissions
- Validation
- Clinical Development
- 21 Cfr Part 11
- Biopharmaceuticals
- Cmc Regulatory Affairs
- Cmc
- Change Control
- Capa
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