Associate Director, Global Regulatory CMC – Remote

Regulatory Jobs; San Carlos (CA); Hybrid; USD 180,000 - 211,000; Full time

Job summary

Vaxcyte in San Carlos, CA is seeking a senior Regulatory CMC professional to lead multi-product global regulatory CMC strategies for investigational products and to manage preparation and filing of CMC submissions.

You will interact with Health Authorities for CMC topics, guide cross-functional teams, and ensure compliance with evolving global regulatory requirements across development programs.

Qualifications

• Bachelor’s degree in a scientific discipline and at least 10 years in vaccine/biotech regulatory CMC.
• Experience drafting BLA, post-approval variations, INDs/IMPDs is highly preferred.
• Experience with health authority meetings and cross-functional teams.
• Strong writing, communication, and ability to meet deadlines.

Responsibilities

• Lead preparation and review of global CMC sections and agency interactions.
• Interpret EMA/FDA/ICH regulations to ensure CMC compliance across teams.
• Define CMC data and documentation requirements for submissions.
• Provide CMC regulatory guidance to cross-functional teams and stakeholders.
• Manage regulatory assessments on product changes, deviations, and GMP investigations.
• Lead projects and serve as the primary regulatory CMC contact for assigned products.
• Represent the company in Health Authority meetings on CMC topics.
• Stay abreast of evolving regulatory CMC requirements and share knowledge.
• Contribute to department strategy and process improvements.

Skills

CMC regulatory knowledge

Regulatory strategy

Cross-functional leadership

Regulatory writing

FDA/EMA/ICH experience

GMP/CMC

Problem solving

Communication skills

Education

Bachelor’s degree in science

Tools

LIMS

SAP

TrackWise

Veeva

Job description

Vaxcyte in San Carlos, CA is seeking a senior Regulatory CMC professional to lead multi-product global regulatory CMC strategies for investigational products and to manage preparation and filing of CMC submissions.

You will interact with Health Authorities for CMC topics, guide cross-functional teams, and ensure compliance with evolving global regulatory requirements across development programs.