Regulatory Affairs Manager CMC

Barrington James; San Francisco (CA); Hybrid; USD 130,000 - 160,000; Full time

Benefits offered by this job

Opportunity to join a global organization

Exposure to U.S. and global regulatory submissions

Work directly with experienced regulatory leadership

Hybrid or onsite working model

Job summary

A well-established global pharmaceutical company is seeking a Regulatory Affairs Manager CMC for its San Francisco team. This role involves developing CMC regulatory strategies and managing submissions like INDs and NDAs, ensuring compliance with regulatory authorities. The position offers exposure to both U.S. and global regulatory processes while working with experienced leadership. A hybrid or onsite working model is available, making it an exciting opportunity to contribute to the company's growth in the pharmaceutical division.

Qualifications

• 7+ years of experience in Regulatory Affairs, focusing on CMC.
• Experience with U.S. and global regulatory filings.
• Ability to work with cross-functional teams.

Responsibilities

• Develop and execute CMC regulatory strategies.
• Prepare and manage regulatory submissions including INDs, NDAs, and BLAs.
• Collaborate with teams to ensure submission alignment.
• Provide regulatory guidance during product development.

Skills

Regulatory Affairs experience

CMC development

Strong understanding of regulatory requirements

Experience with IND, NDA, BLA submissions

Cross-functional collaboration

Education

Bachelor’s or advanced degree in a relevant scientific discipline

Job description

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.
• 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 [e-mail]