Hiring: Associate Director, Regulatory CMC, Biologics Company: Vertex Pharmaceuticals Location: Boston, MA Job Posted Time: 2026-09-12 11:47:33 Employment Type: Hybrid About the job Experience: •8+ years of experience in pharmaceutical or biotechnology industry with a focus on biologics Required Skills: •Leads preparation, review, and lifecycle management of CMC sections of global regulatory submissions for biologics (INDs/CTAs, NDAs/BLAs/MAAs) •Develops and drives global CMC regulatory strategies for assigned programs •Serves as primary regulatory CMC lead for Health Authority interactions •Provides regulatory guidance to cross-functional teams •Leads regulatory assessment of CMC changes, deviations, and investigations •Applies AI-enabled tools for authoring, review, and consistency checks •Drives structured content and data traceability approaches •Supports AI/digital capability development Qualifications: •Bachelor’s degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science field (advanced degree preferred) Compensation: •$166,400 - $249,600 / year •Flexible work environment (work from home / hybrid options) •This role is eligible for an annual bonus and annual equity awards Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!