News

HEAD OF REGULATORY AFFAIRS

October 24, 2018

Sutro Biopharma, Inc. is looking for energetic and talented individuals to join its multidisciplinary research and development team. You will be working to develop new processes to maximize our technology and enhance our internal and collaborative product development initiatives in a fast paced environment.

Responsibilities:

  • Provides regulatory global strategic and operational leadership for the planning, management, support and execution of regulatory activities
  • Defines strategies for, coordinates the execution of including, but not limited to: investigational new drug applications, drug master files, new drug applications and equivalent international filings
  • Advises project teams and collaborates cross-functionally with clinical, preclinical, pharmaceutical development, CMC, commercial and external resources on Regulatory Affairs issues to establish and facilitate global development plans
  • Serves as a primary liaison to US FDA, EMA, and other key market Health Authorities, driving positive interactions and overseeing agency meeting preparation throughout the organization
  • Interprets and applies administrative, legal, and regulatory requirements in compliance with governmental accrediting agencies;
  • Cultivates an open and collaborative culture
  • Builds and manages relationships with key internal and external stakeholders, including cross-functional partners, KOLs, vendors, consultants, and agency authorities
  • Champions new ways of meeting targets and/or goals; anticipates and plans for future issues or problems; facilitates the rapid transfer of best practices
  • Develops and maintains responsive, motivated and efficient teams to ensure results orientation and continuous improvement; develops policies and procedures as appropriate
  • Manages, coaches, and mentors direct and indirect reports

Qualifications:

  • Bachelor’s degree in a scientific discipline is required, advanced degree is a plus
  • Minimum of 10 years of progressively responsible experience in a pharmaceutical, biotechnology, or contract research organization (CRO), including significant experience in a Regulatory Affairs leadership role
  • Oncology experience preferred
  • FDA and EU regulatory experience is required; in-depth knowledge of relevant ICH, FDA and EMA regulatory guidelines and requirements
  • Proven record of success in gaining regulatory approval through relationship building with global health authorities
  • Experience with INDs , CTAs, DMFs, briefing packages, and amendments required during IND and CTA lifecycles; prior experience and success with filing NDAs/MAAs and post-marketing/life cycle management (e.g. variations, renewals, labeling) highly desirable
  • Familiarity with Chemistry, Manufacturing, and Control (CMC), Pharmacovigilance and Quality, related matters and their intersection with Regulatory Affairs
  • Demonstrated leadership ability and experience managing, coaching and mentoring direct reports and building or growing a regulatory affairs function
  • Exceptional relationship-building skills with internal and external stakeholders, including, cross-functional partners, KOLs, vendors, consultants, and agency authorities
  • Excellent verbal and written communication skills; ability to clearly articulate regulatory viewpoints effectively to different functions
  • Successful management of projects to completion meeting budgets and timelines
  • Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities

Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, and stock options.

Please submit resume for Req. #1810 to jobs@sutrobio.com. Please visit our website at www.sutrobio.com for more information.  Local candidates, SF Bay Area.