Remote Regulatory CMC Lead for Global Submissions

Vaxcyte, Inc; San Carlos (CA); On-site; USD 180,000 - 210,500; Full time

Benefits offered by this job

Equity component

Comprehensive benefits

Remote work

Job summary

Vaxcyte, Inc. in the SF Bay Area is seeking an experienced Regulatory CMC leader to develop and execute multi-product global CMC strategies for investigational vaccines.

You will manage interactions with Health Authorities and guide cross-functional teams on CMC documentation and submissions. The role requires a Bachelor's degree in a scientific field and at least 10 years in vaccine/biotech, with experience authoring CMC sections, and familiarity with EMA, FDA, and ICH guidelines.

Qualifications

• Bachelor’s Degree in a scientific discipline.
• 10+ years in vaccine/biotech industry.
• Experience authoring CMC DS sections.
• BLA experience highly preferred; INDs/IMPDs desirable.
• Strong knowledge of FDA/EMA/ICH guidelines.

Responsibilities

• Lead preparation of CMC sections for global submissions.
• Interact with Health Authorities regarding CMC topics.
• Provide CMC guidance to cross-functional teams.
• Define data/documentation requirements for regulatory submissions.
• Monitor evolving regulatory CMC requirements.
• Lead cross-functional projects as primary CMC contact.
• Present at Health Authority meetings when needed.
• Support department strategy development.

Skills

Strategic thinking

Problem solving

Interpersonal skills

Planning and prioritization

Clear communication

Education

Bachelor’s degree in a scientific discipline

Tools

LIMS

SAP

TrackWise

Veeva

Job description

Vaxcyte, Inc. in the SF Bay Area is seeking an experienced Regulatory CMC leader to develop and execute multi-product global CMC strategies for investigational vaccines.

You will manage interactions with Health Authorities and guide cross-functional teams on CMC documentation and submissions. The role requires a Bachelor's degree in a scientific field and at least 10 years in vaccine/biotech, with experience authoring CMC sections, and familiarity with EMA, FDA, and ICH guidelines.