Regulatory Specialist – Chemistry, Manufacturing, and Controls (CMC)

Sutro Biopharma, Inc. is seeking a Regulatory Specialist – Chemistry, Manufacturing, and Controls (CMC) to join their Regulatory team as they change the future of oncology. The role will provide regulatory support in preparation and maintenance of global clinical trial applications, marketing authorizations, and life cycle management with a primary focus on Chemistry, Manufacturing, and Controls (CMC) documentation.

Requirements

• Assist the preparation, review and submissions to regulatory documents (DMFs, INDs, CTAs, BLAs, MAAs, amendments) to support clinical trials and product approvals.
• Coordinate collection and verification of technical data from manufacturing, quality, analytical, and process development teams.
• Help prepare and maintain regulatory dossiers, ensuring consistency, accuracy, and compliance with global requirements.
• Support responses to health authority questions and assist with the preparation of briefing materials for meetings.
• Track regulatory commitments, correspondence, and submission timelines.
• Collaborate with Regulatory Operations on document formatting and eCTD submission readiness.
• Maintain regulatory files and databases in accordance with departmental procedures and standards.

Benefits

• Paid Time Off
• 401k Matching
• Retirement Plan
• Health Insurance
• Dental Insurance
• Vision Insurance