Device CMC Regulatory Lead for Drug-Device Programs

Vertex Pharmaceuticals; United States; On-site; USD 103,000 - 110,000; Full time

Job summary

Vertex Pharmaceuticals in the United States is seeking a Chemistry Manufacturing Controls Manager – Device to lead global regulatory CMC strategies for drug-device combinations and support submissions across development and commercial programs.

You will collaborate with device development, quality, clinical development, human factors, and analytical teams, and may serve as the primary regulatory CMC contact for assigned products and projects, ensuring compliance with FDA, EMA, and ISO standards.

Qualifications

• Bachelor's degree in life-science field or related engineering
• Typically 4 years of experience in medical device/pharma industry or equivalent
• Experience supporting regulatory submissions/filings for combination products
• Experience supporting Human Factors studies for devices and combination products
• Preferred experience with infusion systems/devices for drugs/cell therapies

Responsibilities

• Reviews CMC sections of regulatory submissions in support of development and commercial device programs
• Contributes to development of global regulatory CMC strategies for commercial drug-device products
• Participates on cross-functional teams and may serve as primary regulatory CMC contact for assigned products
• Reviews device development documentation to support design controls for drug-device products
• Supports regulatory assessment and guidance on product compliance topics including change controls and process improvement

Skills

Interpersonal skills

Regulatory knowledge

Regulatory guidelines

Problem solving

Communication

Planning & prioritization

Cross-functional collaboration

Education

Bachelor's degree in life sciences or engineering

Job description

Vertex Pharmaceuticals in the United States is seeking a Chemistry Manufacturing Controls Manager – Device to lead global regulatory CMC strategies for drug-device combinations and support submissions across development and commercial programs.

You will collaborate with device development, quality, clinical development, human factors, and analytical teams, and may serve as the primary regulatory CMC contact for assigned products and projects, ensuring compliance with FDA, EMA, and ISO standards.