Global Regulatory CMC Manager - Biologics Submissions

Atrium; Boston (MA); On-site; USD 103,000 - 110,000; Full time

Job summary

Vertex Pharmaceuticals is seeking a CMC Manager to support multi-product regulatory CMC activities for marketed biologics and drugs. The role emphasizes preparation and submission of CMC documentation and cross-functional regulatory support.

You will lead US/CA/EU lifecycle submissions, review CMC sections and agency interactions, and work with development teams to shape global CMC strategies and responses.

Qualifications

• Bachelor's degree in life sciences or related field.
• Typically 4 years of pharmaceutical industry experience or equivalent.
• Experience with regulatory (FDA/EMA/Health Canada/ICH) guidelines preferred.

Responsibilities

• Execute lifecycle management (LCM) strategies and submissions focusing on US/CA/EU.
• Review CMC sections of regulatory submissions and agency communications.
• Collaborate with regulatory teams to develop global CMC strategies and submissions.
• May serve as the primary regulatory CMC contact for assigned products/projects.

Skills

Interpersonal skills

Regulatory guidelines

Problem solving

Collaboration & communication

Planning & prioritization

cGMP knowledge

Education

Bachelor's degree in life sciences

Job description

Vertex Pharmaceuticals is seeking a CMC Manager to support multi-product regulatory CMC activities for marketed biologics and drugs. The role emphasizes preparation and submission of CMC documentation and cross-functional regulatory support.

You will lead US/CA/EU lifecycle submissions, review CMC sections and agency interactions, and work with development teams to shape global CMC strategies and responses.