Aksha Gupta
Regulatory Compliance Analyst @Spectrum Chemical Mfg. Corp.
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WORK HISTORY
Regulatory Compliance Analyst @Spectrum Chemical Mfg. Corp.
NJ, US
Conducted analysis of regulated items reports and prioritized critical export/import compliance transactions, ensuring adherence to DEA, FDA, and other regulatory standards.• Reviewed customer documentation for accuracy and compliance, prepared DEA/CA DOJ export/import reports, and updated transactions based on regulatory requirements.• Coordinated with customers, sales teams, and managers to resolve documentation issues and expedite order clearance processes.• Performed data entry into ERP systems, created regulatory memos, and prepared reports, including EHS assessments and API NDC submissions.• Prepared product end-use letters and TSCA declarations to ensure compliance during the import clearance process.• Reviewed inbound and outbound shipments for import/export compliance, including export licenses, duty drawback, FDA clearance, harmonized tariff codes, and FCC regulations.
EDUCATION
Northeastern University
Master's degree
Noida Institute of Engineering & Technology
Bachelor of Pharmacy - BPharm
SKILLS
ABOUT AKSHA GUPTA
Quality & Regulatory professional with hands‑on experience in Quality Systems, CAPA…
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