Regulatory CMC Manager, Cell & Gene Therapy

Vertex Pharmaceuticals LLC; United States; Remote; USD 96,000 - 110,000; Full time

Job summary

Vertex Pharmaceuticals LLC seeks a Regulatory CMC Manager to drive international CMC submissions and regulatory strategies for cell and gene therapy programs. You will collaborate with cross-functional teams to ensure regulatory requirements are integrated throughout the product lifecycle.

The role involves planning, preparing, and submitting CMC documentation, providing guidance on FDA/EMA and international guidelines, and supporting post-approval changes in a global setting.

Qualifications

• Bachelor's degree in life sciences or related field.
• 5+ years of Regulatory CMC experience including cell & gene therapy.
• Proficiency with FDA, EMA and international regulatory guidelines.
• Experience in preparation, reviews and submissions of CMC post-approval variations.

Responsibilities

• Plan and execute international regulatory CMC submissions with content plans and cross-functional alignment.
• Review CMC sections of regulatory submissions and responses with agencies.
• Contribute to global regulatory CMC strategy for commercial products.
• Collaborate with regulatory and technical teams to ensure timely post-approval CMC changes.
• Provide regulatory CMC guidance to cross-functional teams and stakeholders.

Skills

Regulatory CMC leadership

Cell & Gene Therapy

FDA EMA guidelines

Regulatory submissions

Education

Bachelor's degree in Life Sciences or related field

Job description

Vertex Pharmaceuticals LLC seeks a Regulatory CMC Manager to drive international CMC submissions and regulatory strategies for cell and gene therapy programs. You will collaborate with cross-functional teams to ensure regulatory requirements are integrated throughout the product lifecycle.

The role involves planning, preparing, and submitting CMC documentation, providing guidance on FDA/EMA and international guidelines, and supporting post-approval changes in a global setting.