Experience

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  Cvs health

  Apr 2015 - May 2016

  Pharmacy technician i

  • Verified and processed prescriptions with attention to detail• Managed insurance claims and ensured accurate prescription preparation• Maintained medication inventory and upheld HIPAA regulations• Provided professional service during prescription pick-up and transactions

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  Old dominion university

  Aug 2016 - Dec 2018

  • Conducted toxicity research on nanomaterials in zebrafish• Utilized NMR to investigate the chemical structure of RNA involved in the Picornavirus replication complex• Collaborated in optimizing the expression of Prostate Apoptosis Response-4 (Par-4) protein in Escherichia coli• Ensured compliance with procedures and protocols• Managed chemical inventory and facilitated procurement processes• Managed biohazardous waste disposal and maintained laboratory cleanliness • Devised effective methodologies for clear communication of critical concepts• Delivered comprehensive instruction and supervised laboratory experiments• Provided educational support to clarify key concepts and assist with assignments

  • Graduate Research Assistant

    Aug 2016 - Dec 2018

  • Graduate Teaching Assistant

    Aug 2016 - Dec 2018
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  Registrar corp

  Jan 2021 - now

  Regulatory specialist in product, labeling, and ingredient review department

  • Conduct extensive regulatory research on FDA guidelines and federal regulations, specifically focusing on labeling requirements across a wide array of product categories, including but not limited to foods, dietary supplements, OTC drugs, and cosmetic products• Utilize scientific methods and analytical approaches to scrutinize client labeling and marketing materials for compliance violations• Engage directly with clients to understand their regulatory compliance needs and concerns• Prepare detailed reports outlining relevant regulations and potential compliance challenges• Communicate adeptly with clients, including foreign manufacturers exporting to the USA, to resolve regulatory inquiries and ensure adherence to compliance standards• Maintain and validate technical files essential for FDA submissions and other regulatory procedures Show less

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  Aroga biosciences

  Dec 2023 - Mar 2024

  Regulatory medical writer

  • Managed multiple projects with various clients, ensuring adherence to medical writing timelines• Led strategy and development plan meetings such as Kick-Off Meetings (KOMs) and Comment Resolution Meetings (CRMs)• Collaborated within interdisciplinary teams, providing insight on content, format, and style-guide compliance in alignment with regulatory guidelines• Authored, co-authored, critically edited, and formatted regulatory documents spanning Phase 1-3 clinical studies• Maintained up-to-date subject area expertise and adhered to regulatory and publication guidelines• Employed software solutions such as Veeva Vault-RIM, SharePoint, Box, StartingPoint “Author” toolbar, and Perfect It to streamline writing processes Show less