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Regulatory AffairsBiotechnologyMid–Senior
Regulatory Affairs CMC Specialist
Cambridge, MAPermanent$120,000 – $150,000Posted 3 weeks ago
About the role
Own CMC regulatory submissions for a biologics portfolio, coordinating with manufacturing and quality.
What you’ll do
- Prepare Module 3 content for INDs, BLAs, and lifecycle changes.
- Assess manufacturing changes for regulatory impact.
- Coordinate responses to agency CMC questions.
- Maintain regulatory compliance across the product lifecycle.
What you’ll bring
- 5+ years in CMC regulatory affairs for biologics.
- Understanding of ICH Q8–Q12 and comparability.
- Strong technical writing and cross-functional coordination.
- Scientific degree in a relevant discipline.
Bektin is an equal-opportunity partner. We present every qualified candidate on merit and keep your details confidential until you approve a submission.