Regulatory Affairs CMC Consultant - Insulin Biosimilars Outside IR35
JOB_53350734712876Job type
ContractLocation
LondonWorking Pattern
Part-time,Specialism
Regulatory AffairsIndustry
PharmaceuticalsPay
Outside IR35
Regulatory CMC | FDA | BIOSIMILARS | INSULIN | OUTSIDE IR35
Regulatory Affairs Consultant – CMC Strategy for Insulin Biosimilars (Part-Time / Contract)
Remote in UK | Contract | Biotech | Advanced Biomanufacturing
Remote in UK | Contract | Biotech | Advanced Biomanufacturing
This biotech is pioneering the production of recombinant insulin. They are working with CDMOs to scale their biomanufacturing platform and are now seeking a highly experienced Regulatory Affairs CMC Consultant to support the regulatory strategy and FDA interactions.
What We’re Looking For
We’re seeking a consultant with a strong track record in regulatory affairs, specifically in CMC strategy for insulin biosimilars.
The ideal candidate will have:
✅ Experience with FDA approvals for insulin or insulin biosimilars
✅ CMC regulatory filing experience for novel biomanufacturing platforms
✅ Hands-on knowledge of GMP biomanufacturing or fermentation, including working with CDMOs and setting up GMP-compliant equipment and processes
✅ CMC regulatory filing experience for novel biomanufacturing platforms
✅ Hands-on knowledge of GMP biomanufacturing or fermentation, including working with CDMOs and setting up GMP-compliant equipment and processes
Your Role Will Include
- Leading regulatory strategy and authoring CMC sections for FDA submissions
- Supporting comparability studies to demonstrate equivalence of our platform to existing insulin manufacturing methods
- Advising on GMP documentation and facility readiness in collaboration with our CDMO partners
Interested?
If you meet the criteria and are excited by the opportunity to shape regulatory strategy for a breakthrough technology, we’d love to hear from you. Apply now or reach out for an initial conversation. You must have experience with insulin biosimilars.
Your CV will not be successful for this role unless you have insulin biosimilars FDA experience.
If you meet the criteria and are excited by the opportunity to shape regulatory strategy for a breakthrough technology, we’d love to hear from you. Apply now or reach out for an initial conversation. You must have experience with insulin biosimilars.
Your CV will not be successful for this role unless you have insulin biosimilars FDA experience.
Regulatory Affairs CMC Consultant - Insulin Biosimilars Outside IR35JOB_533507347128762025-08-012025-10-30
Talk to Julia Bowden, the specialist consultant managing this position
Located in London-City, 5th Floor, 107 Cheapside, Telephone +443330106057Click here to access our Privacy Policy, which provides detailed information on how we use and protect your personal information, and your rights in relation to this.
JOB_53350734712876