SENIOR MANAGER, REGULATORY AFFAIRS

Senior Manager, Regulatory Affairs Position Overview Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in the oncology and auto‑immune disease space. Our portfolio includes antibody‑drug conjugates, bispecific antibodies, cytokine derivatives and other novel immuno‑stimulatory approaches. Sutro Biopharma, Inc. is looking for a Senior Manager who provides regulatory leadership in development and execution of strategies in support of the global clinical trial applications, and life‑cycle management of an expanding oncology portfolio. Experience in oncology drug development is strongly preferred. Responsibilities Provide strong regulatory and scientific leadership to cross‑functional teams ensuring that the developmental plan provides optimal scientific positioning and highest regulatory probability of success. Contributes and/or leads regulatory department initiatives. Supports the preparation, review, and planning of submissions to regulatory agencies including FDA and other global Health Authorities. Supports the conduct of clinical trials and approval of marketing applications while holding responsibility for the maintenance of these applications (INDs, CTAs, DMFs, BLAs, MAAs). Ensures regulatory documents are developed with high quality, delivered in a timely manner, and are consistent with corporate strategy and compliant with current global regulatory requirements. Serves as one of the points of contact with Regulatory Agencies and supports communication/meeting strategy development and execution. Facilitates preparation of briefing materials, responses to Health Authority questions, anticipates issues, and provides guidance to cross‑functional teams on risk mitigation strategies. Works with regulatory operations to archive correspondence and develop submission plans and timelines. Monitors, analyzes, and disseminates intelligence on regulatory matters that may affect ongoing development programs. Qualifications Bachelor’s degree in Life/Health Sciences; Master’s degree and/or Pharm.D. or Ph.D. a plus. Minimum of 5–6 years of experience in pharmaceutical/biotech with minimum 4 years in Regulatory Affairs. Strong technical and analytical skills with ability to make data‑driven decisions. Strong written and oral communication skills. Strong leadership, negotiation, and collaboration skills. Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve organizational goals. Thorough knowledge of U.S. and international regulations as they apply to drug and biologic development with understanding of expedited approval pathways is a plus. Considerable experience supporting regulatory agency interactions (FDA meetings, EMA Scientific Advice, Advisory Committees, Oral Explanations, etc.) is a plus. Experience managing the development of INDs, global clinical trial applications and BLAs/MAAs is a plus. Office based position with some travel (domestic and international), up to 25%. 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. #J-18808-Ljbffr