Regulatory CMC Lead, Biologics — AI-Driven Submissions

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 166,000 - 250,000; Full time

Benefits offered by this job

Medical, dental and vision benefits

Generous paid time off

Educational assistance programs

Commuting subsidy

Matching charitable donations

401(k)

Job summary

Vertex Pharmaceuticals Inc in the United States seeks a CMC Associate Director to lead global regulatory CMC strategies for biologics. You will author, review, and deliver high-quality regulatory submissions while interfacing with Health Authorities.

In this hybrid role, you will drive AI-enabled document preparation, ensure data traceability, and guide cross-functional teams to accelerate innovative therapies for patients.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science field (advanced degree preferred).
• 8+ years in pharma/biotech with biologics focus and CMC submissions experience.
• HA interactions for biologics experience desirable.

Responsibilities

• Lead preparation, review, and lifecycle management of CMC sections for biologics regulatory submissions.
• Develop 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 content and data traceability approaches.
• Support AI/digital capability development and innovations.
• Represent Regulatory CMC in governance forums.
• Stay abreast of regulatory tech advances and AI opportunities.

Skills

CMC regulatory strategy

Cross-functional leadership

Regulatory submissions

AI-enabled regulatory

Digital & AI capabilities

Strategic thinking

Communication skills

Global matrix experience

Quality & compliance

People management (optional)

AI output review

Data traceability

Automation opportunities

Education

Bachelor’s degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science field

Tools

AI tools for regulatory

Job description

Vertex Pharmaceuticals Inc in the United States seeks a CMC Associate Director to lead global regulatory CMC strategies for biologics. You will author, review, and deliver high-quality regulatory submissions while interfacing with Health Authorities.

In this hybrid role, you will drive AI-enabled document preparation, ensure data traceability, and guide cross-functional teams to accelerate innovative therapies for patients.