CMC Consultant (Phase 3) – Biotech/Pharma
We’re looking for an experienced CMC Consultant to drive process development, scale-up, and regulatory submission activities as we move towards NDA submission & commercial readiness. If you thrive in fast-paced biotech environments and have a track record of CMC leadership in Phase 3 trials, we want to hear from you!
Your Impact:
✔ Develop & execute CMC strategies for clinical & commercial success
✔ Oversee GMP manufacturing, process validation & tech transfer
✔ Prepare & review CMC sections of regulatory filings (INDs, NDAs, BLAs)
✔ Ensure compliance with FDA, EMA & ICH guidelines
✔ Collaborate with R&D, Regulatory, Quality, Clinical Ops & external vendors
What You Bring:
✅ 8+ years of CMC experience in biotech/pharma (topical anti-fungal preferred)
✅ Hands-on expertise in GMP manufacturing, scale-up & regulatory submissions
✅ Deep knowledge of analytical methods & process development
✅ Strong regulatory acumen & ability to navigate agency queries
✅ Exceptional problem-solving & project management skills
Competitive compensation – flexible structure.
This is your chance to shape a game-changing biotech project at a pivotal stage! Ready to make an impact? Apply now
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