CMC Compliance Lead for Global Clinical Manufacturing

University of California - San Francisco; San Francisco (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

University of California, San Francisco (UCSF) seeks a Senior Regulatory/CMC professional to provide strategic oversight of CMO activities for complex, multi-site trials. You will manage regulatory submissions, QC documentation, and ensure compliance with FDA/EMA guidelines across global operations.

Responsibilities include leading cross-functional teams, overseeing timelines and budgets, and coordinating with Regulatory Affairs to address agency questions, ensuring quality and compliance in all

Qualifications

• Bachelor's degree required and 5+ years of related experience.
• Advanced knowledge of regulatory requirements and GMP principles.
• Experience preparing, reviewing, and finalizing CMC sections for regulatory submissions (e.g., INDs).
• Ability to communicate complex scientific data to technical and non-technical audiences.

Responsibilities

• Lead and coordinate cross-functional teams to ensure seamless CMO product development.
• Develop and maintain detailed CMC project timelines from development to lifecycle management.
• Review and approve key technical documentation including batch records, validation reports, and specifications.
• Ensure adherence to cGMP and data integrity standards across all CMC activities.
• Collaborate with Regulatory Affairs to address agency questions and ensure timely submissions.

Skills

Regulatory affairs

cGMP knowledge

Cross-functional leadership

Project management

Communication skills

Risk management

Quality systems

Writing

Education

Bachelor's degree in related areas

Master's or PhD in related area

Job description

University of California, San Francisco (UCSF) seeks a Senior Regulatory/CMC professional to provide strategic oversight of CMO activities for complex, multi-site trials. You will manage regulatory submissions, QC documentation, and ensure compliance with FDA/EMA guidelines across global operations.

Responsibilities include leading cross-functional teams, overseeing timelines and budgets, and coordinating with Regulatory Affairs to address agency questions, ensuring quality and compliance in all