Chiazoka O.
Senior Regulatory Affairs Specialist | Expert in FDA Submissions & Compliance | Passionate About Healthcare Innovation
- Role
- Regulatory Affairs Specialist Ii at Technical Resources International, Inc.
- Location
- Silver Spring, MD, US
- LinkedIn followers
- 500 followers
About Chiazoka O.
With over 4 years of experience as a Regulatory Affairs Specialist, I specialize in supporting the development and approval of new drugs and devices for infectious diseases. I collaborate with multidisciplinary teams, FDA reviewers, and external stakeholders to ensure compliance with regulatory standards and best practices. My passion for compliance and quality assurance drives me to ensure products meets the highest standards, ultimately improving patient outcomes.
Experience
Regulatory Affairs Specialist Ii
Technical Resources International, Inc.
Sep 2023 — Present
I played a crucial role in supporting regulatory compliance for NIH-sponsored studies, significantly improving document accuracy and efficiency. • Ensured all regulatory documents adhered to FDA and ICH guidelines, facilitating smooth study operations. • Collaborated with cross-functional teams to address queries, enhancing communication and compliance processes. • Developed best practices for document preparation, resulting in a more streamlined regulatory submission process.
Education
CUNY Bronx Community College
Associate of Science - AS, Chemistry
University of Maryland Eastern Shore
Doctor of Pharmacy - PharmD, Pharmacy
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