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Regulatory Affairs Associate — FDA Submissions & Strategy

Job in Raleigh, Wake County, North Carolina, 27601, USA
Listing for: Azurity Pharmaceuticals - US
Full Time position
Listed on 2026-07-10
Job specializations:
  • Quality Assurance - QA/QC
  • Healthcare
Salary/Wage Range or Industry Benchmark: 75000 - 110000 USD Yearly USD 75000.00 110000.00 YEAR
Job Description & How to Apply Below

Azurity Pharmaceuticals seeks a Regulatory Affairs Associate/Senior Associate to assist in preparing, reviewing, and submitting regulatory filings to the FDA and global agencies. You will contribute to lifecycle management of IND, NDA, ANDA, and related activities across product lines.

You will collaborate with Technical Operations, Quality Assurance, Clinical Development, and Medical Affairs to ensure compliant submissions and timely regulatory decisions while maintaining meticulous records and

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Position Requirements
10+ Years work experience
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