CMC Regulatory Manager — Hybrid/Remote

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 103,000 - 155,000; Full time

Benefits offered by this job

Medical benefits

Paid time off

Student loan repayment

Commuting subsidy

Matching charitable donations

401(k)

Job summary

Vertex is seeking a Chemistry Manufacturing Controls Manager in Boston to lead regulatory CMC submissions for investigational and commercial products. You will partner with global teams to shape regulatory CMC strategies and coordinate responses with agencies.

The role requires a BS in chemistry/related field and 4+ years in CMC, with hands-on experience in FDA/EMA/ICH frameworks, Veeva publishing, and cross-functional collaboration.

Qualifications

• Prepare and write CMC submissions for IND and marketed products.
• Assess post-approval changes for regulatory impact in global markets.
• Support regulatory inspections and readiness from a CMC perspective.
• Utilize Veeva for regulatory submissions.
• Apply cGMP regulatory frameworks including FDA/EMA/ICH.

Responsibilities

• Review CMC sections of regulatory submissions and agency interactions.
• Contribute to global regulatory CMC strategies for investigational and commercial products.
• Collaborate with regulatory colleagues on global CMC strategies and submissions.
• Provide regulatory CMC guidance to cross-functional teams and stakeholders.
• Influence regulatory assessments on product changes, deviations, and GMP investigations.
• Serve as primary regulatory CMC contact for assigned products and projects.
• Contribute to multi-product global regulatory CMC strategies for investigational and marketed products.
• Prepare and submit regulatory CMC documentation and interact with health authorities.

Skills

CMC regulatory submissions

Global regulatory strategy

Regulatory communications

Veeva publishing

cGMP knowledge

Cross-functional collaboration

Education

Bachelor's degree in Chemistry/Regulatory Affairs

Tools

Veeva

Job description

Vertex is seeking a Chemistry Manufacturing Controls Manager in Boston to lead regulatory CMC submissions for investigational and commercial products. You will partner with global teams to shape regulatory CMC strategies and coordinate responses with agencies.

The role requires a BS in chemistry/related field and 4+ years in CMC, with hands-on experience in FDA/EMA/ICH frameworks, Veeva publishing, and cross-functional collaboration.