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Senior Associate, Regulatory CMC

Remote, USA Full-time Posted 2026-07-23

5+ years pharmaceutical/biotech CMC experience, expertise in biologics/cell therapy CMC, CMC writing and submissions, regulatory inspection support, and risk-based lifecycle management.

Key Responsibilities

  • preparing submissions
  • managing compliance
  • assessing risk

Job Details

  • Category: Research and Development (R&D)
  • Seniority: Senior Level
  • Commitment: Full Time
  • Workplace: Remote — Durham or United States
  • Languages: English

Benefits

  • 401k matching
  • Generous reputed company time off
  • Retirement plan

About reputed company

A biotechnology company developing bioengineered reputed company tissues and advanced tissue constructs for therapeutic use. — Industry: Research and Development

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