Senior Manager, Regulatory Affairs

Sutro Biopharma•South San Francisco, CA

1d•Onsite

About The Position

Sutro Biopharma, Inc. is looking for a Senior Manager, Regulatory Affairs 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.

Requirements

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
Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve organizational goals
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

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 point s 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.