Aksha Gupta
Regulatory Compliance Analyst
- Role
- Regulatory Compliance Analyst at Spectrum Chemical Mfg. Corp.
- Location
- Woburn, MA, US
- LinkedIn followers
- 500 followers
About Aksha Gupta
Quality & Regulatory professional with hands‑on experience in Quality Systems, CAPA…
Experience
Regulatory Compliance Analyst
Aug 2024 — Present · 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
2022 — 2023
Noida Institute of Engineering & Technology
Bachelor of Pharmacy - BPharm
2013 — 2017
Skills
- Microsoft Excel
- Marketing
- Customer Service
- Microsoft Office
- Sales
- Public Speaking
- Leadership
- Strategic Planning
- Microsoft Word
- Management
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