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. This individual will support interactions with global Health Authorities and serve as our regulatory representative on cross-functional development teams. 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, 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.
• Maintains awareness of regulatory matters that may affect ongoing development programs.

Qualifications

• Bachelor’s degree 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.
• Thorough knowledge of US and international regulations as they apply to drug and biologic development with the 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%.