What are the responsibilities and job description for the Regulatory CMC Consultant (Contract) position at IO Associates?
Job Details
Contract Role: Regulatory CMC Consultant (Biotech, CDMO-heavy)
Boston-Based Biotech | Remote Flex | 3-6 Month Contract (Extendable)
I'm currently recruiting on behalf of a Boston-area biotech that's scaling quickly and heading into a critical regulatory phase. They're looking to bring on a Regulatory CMC Consultant, someone who's been directly involved with Module 3, CDMO oversight, and global filings, and can operate as an embedded expert during this next stretch of growth.
This is an early- to mid-stage company with a strong pipeline and external manufacturing model. They've got great science, tight timelines, and a lean internal regulatory function-so they need someone who can drop in, take ownership, and guide key CMC deliverables across development and early commercial readiness.
The key focus areas include:
- IND/CTA Module 3 prep and authoring
- CMC gap assessments for EU and rest-of-world markets
- Post-approval variation filings (EU/UK)
- Tech transfer / site transfer / scale-up support, interfacing with CDMOs and internal Tech Ops/QA
The ideal candidate has:
- 7 years of Regulatory CMC experience in biotech (small teams, not just big pharma)
- Strong experience with CDMO-heavy environments and global Module 3 strategy
- Confidence working cross-functionally and independently
- Bonus: experience with biologics or complex modalities
Contract Details:
- 3-6 months to start, with potential extension
- Remote-flexible, East Coast hours preferred
- Competitive hourly rate, depending on experience
- Start: ASAP
This role would be a great fit for someone who enjoys working hands-on with scaling biotechs and thrives in fast-paced, cross-functional environments.
