Bethel Ameh
Licensed Pharmacist | Regulatory Affairs Professional | Expert in Compliance | MS in Regulatory Affairs
- Role
- Regulatory Operations Consultant at Avant Grobel
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
About Bethel Ameh
Regulatory Affairs Professional and licensed Pharmacist with over 5 years leading…
Experience
Regulatory Operations Consultant
Nov 2023 — Present
Leading the complete regulatory lifecycle management to market products with zero compliance issues.Developing and implementing comprehensive quality system procedures for pharmaceutical clients to establish frameworks that ensure regulatory compliance while optimizing operational efficiency.Overseeing document control efforts, including drafting, reviewing, and updating SOPs and DMRs, quality manuals, and regulatory documentation, guaranteeing compliance.Cross-functionally collaborating with internal teams and external stakeholders to execute regulatory submissions, implement proactive risk assessment protocols, and validate critical supply chain processes in alignment with ICH requirements.
Education
Northeastern University
Master of Science - MS, Regulatory Affairs
University of Port Harcourt
Bachelor of Pharmacy - BPharm, Pharmacy
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