Regulatory CMC Associate Director — Biologics (AI Submissions)

Vertex Pharmaceuticals Incorporated

Boston (MA)

Hybrid

USD 166,400 - 249,600

Full time

14 days+

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Benefits offered by this job

Hybrid-Eligible

On-Site Eligible

Job summary

Vertex Pharmaceuticals Incorporated is seeking an Associate Director of Chemistry Manufacturing Controls (CMC) to lead global regulatory strategies for biologics. You will author, review, and deliver high-quality regulatory submissions and serve as the primary CMC interface with Health Authorities, leveraging AI-enabled tools to enhance efficiency and data integrity.

Requires 8+ years in pharma/biotech with biologics, strong cross-functional leadership, and expertise in global CMC requirements.

Qualifications

Bachelor's degree in a life science field; advanced degree preferred.
8+ years in pharmaceutical/biotech with biologics focus.
Experience leading CMC submissions and HA interactions for biologics.
Experience with complex or multi-product strategies preferred.

Responsibilities

Lead preparation, review, and lifecycle management of CMC sections for global regulatory submissions (biologics).
Develop and drive global CMC regulatory strategies for assigned programs.
Serve as primary regulatory CMC lead for Health Authority interactions.
Provide regulatory guidance to cross-functional teams.
Lead regulatory assessment of CMC changes, deviations, and investigations.
Apply AI-enabled tools for authoring, review, and consistency checks.
Drive structured content and data traceability approaches.
Support AI/digital capability development.
Contribute to process improvements and innovation initiatives.
Represent Regulatory CMC in governance forums.
Stay abreast of advances in technology and AI; adapt regulatory CMC decision-making.