Global Regulatory CMC Lead for Biologics Submissions

Vertex Pharmaceuticals LLC; United States; Remote; USD 103,000 - 110,000; Full time

Job summary

Vertex Pharmaceuticals in the United States is seeking a Regulatory CMC Manager to support multi-product global regulatory CMC activities for marketed products, with a focus on Biologics and regulatory submissions.

The role contributes to the preparation and submission of regulatory CMC documentation, reviews CMC sections of submissions, collaborates with FDA/EMA/Health Canada teams, and serves as a primary CMC contact for assigned products and projects, ensuring timely, compliant deliverables.

Qualifications

• Bachelor's degree in a life-science field (Biology, Chemistry, Pharmacy, Regulatory Affairs, Biologics or Medical Devices).
• Typically requires 4 years of pharmaceutical industry experience or equivalent combination of education and experience.

Responsibilities

• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU.
• Review CMC sections of regulatory submissions and manage agency interactions.
• Collaborate on global regulatory CMC strategies and submissions.
• May serve as the primary regulatory CMC contact for assigned products and projects.

Skills

Regulatory guidelines

Cross-functional communication

cGMP knowledge

Problem-solving

Prioritization

Education

Bachelor's degree in life sciences/related field

Job description

Vertex Pharmaceuticals in the United States is seeking a Regulatory CMC Manager to support multi-product global regulatory CMC activities for marketed products, with a focus on Biologics and regulatory submissions.

The role contributes to the preparation and submission of regulatory CMC documentation, reviews CMC sections of submissions, collaborates with FDA/EMA/Health Canada teams, and serves as a primary CMC contact for assigned products and projects, ensuring timely, compliant deliverables.