Job Details

Regulatory Affairs Manager CMC

San Fran - Hybrid/Onsite

We are partnering with a well-established global pharmaceutical and combination product company that has been operating for over 20 years and is currently expanding its pharmaceutical division. As part of this growth, the organization is seeking a Regulatory Affairs Manager CMC to join their Regulatory team in San Francisco.

This is an exciting opportunity to play a hands-on role in regulatory strategy and submissions, supporting both U.S. and global regulatory filings while working closely with cross-functional teams across development, CMC, and quality. The role will report directly to the Director of Regulatory Affairs and contribute to advancing development programs through key regulatory milestones.

Key Responsibilities

• Develop and execute CMC regulatory strategies to support global development programs.
• Prepare, review, and manage regulatory submissions including INDs, NDAs, BLAs, and global equivalents.
• Lead the CMC sections of regulatory dossiers, ensuring compliance with FDA, EMA, and other global regulatory authorities.
• Collaborate cross-functionally with CMC, Manufacturing, Analytical Development, Quality, and Clinical teams to ensure alignment on regulatory strategy and submission timelines.
• Provide regulatory guidance during product development, including process development, manufacturing changes, and lifecycle management.
• Support regulatory agency interactions, including responses to information requests and preparation for meetings with regulatory authorities.
• Ensure regulatory documentation is maintained in accordance with global regulatory requirements and internal procedures.
• Monitor evolving regulatory guidelines and communicate potential impacts to development programs.

Qualifications

• Bachelor's or advanced degree in a relevant scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences, or related field).
• 7+ years of Regulatory Affairs experience, with a strong focus on CMC within the biopharmaceutical industry.
• Demonstrated experience supporting IND, NDA, or BLA submissions and global regulatory filings.
• Experience interacting with FDA and international regulatory agencies (EMA experience preferred).
• Strong understanding of CMC development, manufacturing processes, and regulatory requirements.
• Experience with combination products or device components is beneficial but not required.

Why Join

• Opportunity to join a well-established global organization expanding its pharmaceutical division.
• Hands-on regulatory role supporting impactful development programs.
• Exposure to U.S. and global regulatory submissions.
• Work directly with experienced regulatory leadership.
• Hybrid or onsite working model available in San Francisco as the company continues to build out its pharmaceutical team.

Apply today or reach out directly with your CV to ...@barringtonjames.com