Global Regulatory CMC Lead – Biologics

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

Job summary

Vertex Pharmaceuticals in Boston seeks a Regulatory CMC Manager to support multi-product regulatory CMC for marketed products, including preparation and submission of CMC documentation for clinical trials and cross-functional regulatory support with a biologics focus.

The role requires a biology/chemistry/Regulatory Affairs background with 4 years of pharma experience and strong knowledge of FDA, EMA, and ICH guidelines. Collaboration and planning are essential in a fast-paced environment.

Qualifications

• Bachelor's degree in biology, chemistry, pharmacy, regulatory affairs or related life-science field.
• Typically requires 4 years of pharma industry experience or equivalent.
• Strong interpersonal and regulatory guidelines knowledge.
• Ability to collaborate and communicate clearly across teams.
• Sound knowledge of cGMP, FDA, EMA and ICH.

Responsibilities

• Execute lifecycle management strategy for CMC submissions focusing on US/CA/EU.
• Review CMC sections of regulatory submissions and agency interactions.
• Develop global regulatory CMC strategies and submissions.
• Serve as the primary regulatory CMC contact for assigned products and projects.

Skills

Regulatory guidelines

Interpersonal skills

cGMP knowledge

Cross-functional collaboration

Planning

Problem solving

Education

Bachelor's degree in life sciences

Tools

Regulatory submissions software

Job description

Vertex Pharmaceuticals in Boston seeks a Regulatory CMC Manager to support multi-product regulatory CMC for marketed products, including preparation and submission of CMC documentation for clinical trials and cross-functional regulatory support with a biologics focus.

The role requires a biology/chemistry/Regulatory Affairs background with 4 years of pharma experience and strong knowledge of FDA, EMA, and ICH guidelines. Collaboration and planning are essential in a fast-paced environment.