Sutro Biopharma, Inc
Regulatory Specialist – Chemistry, Manufacturing, and Controls (CMC)
Sutro Biopharma, Inc, California, Missouri, United States, 65018
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).msg.
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’we 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.
Qualifications:
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; Master’s degree and/or Ph.D. a plus.
1–3 years of experience in Regulatory Affairs or related biopharmaceutical development functions (e.g., quality, CMC Hickish technical writing). Experience with Drug Master Files (DMF), electronic document management systems or eCTD submissions a plus.
Sound exciting? Apply today and join our team! Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for Stitch for COVID‑19 prior to the first date of employment.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third‑party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $155,000 - $177,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration ofèi experience, the type and length of experience within the industry and education.
About Sutro Biopharma Sutro Biopharma, Inc. is advancing a next‑generation antibody‑drug conjugate (ADC) platform designed to deliver single- and dual‑payload ADCs that enable meaningful breakthroughs for patients with cancer. By fully optimizing the antibody, linker, and payload, Sutro’s cell‑free platform produces ADCs that are engineered to improve drug exposure, reduce side effects, and expand the range of treatable tumor types. With unique capabilities in dual‑payload ADCs, Sutro aims to overcome treatment resistance and redefine what’s possible in cancer therapy. The Company’s pipeline of single- and dual‑payload ADCs targets large oncology markets with limited treatment options and significant need for improved therapies.
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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’we 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.
Qualifications:
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; Master’s degree and/or Ph.D. a plus.
1–3 years of experience in Regulatory Affairs or related biopharmaceutical development functions (e.g., quality, CMC Hickish technical writing). Experience with Drug Master Files (DMF), electronic document management systems or eCTD submissions a plus.
Sound exciting? Apply today and join our team! Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for Stitch for COVID‑19 prior to the first date of employment.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third‑party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $155,000 - $177,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration ofèi experience, the type and length of experience within the industry and education.
About Sutro Biopharma Sutro Biopharma, Inc. is advancing a next‑generation antibody‑drug conjugate (ADC) platform designed to deliver single- and dual‑payload ADCs that enable meaningful breakthroughs for patients with cancer. By fully optimizing the antibody, linker, and payload, Sutro’s cell‑free platform produces ADCs that are engineered to improve drug exposure, reduce side effects, and expand the range of treatable tumor types. With unique capabilities in dual‑payload ADCs, Sutro aims to overcome treatment resistance and redefine what’s possible in cancer therapy. The Company’s pipeline of single- and dual‑payload ADCs targets large oncology markets with limited treatment options and significant need for improved therapies.
#J-18808-Ljbffr