Regulatory Specialist – Chemistry, Manufacturing, and Controls (CMC)
About The Position
Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Regulatory team as we change the future of oncology. You 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. Working closely with cross-functional teams, this position contributes to the development and life cycle management of Sutro’s oncology portfolio in compliance with applicable regulatory requirements. We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.
Requirements
- Basic knowledge of US and international regulations as they apply to drug and biologic development
- Strong technical and analytical skills with ability to make data-driven decisions
- Strong written and oral communication skills
- Bachelor’s degree Life/Health Sciences
- 1–3 years of experience in Regulatory Affairs or related biopharmaceutical development functions (e.g., quality, CMC, or technical writing). Experience with Drug Master Files (DMF), electronic document management systems or eCTD submissions a plus
Nice To Haves
- Master’s degree and/or Ph.D. a plus
- Experience with Drug Master Files (DMF), electronic document management systems or eCTD submissions a plus
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
251-500 employees
