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 energetic and talented individuals to join its multidisciplinary research and development team. The Director, Regulatory Affairs will be responsible for leading strategic global activities. You will collaborate and advise on regulatory affairs cross-functionally and externally to establish and facilitate global development plans for Sutro’s portfolio of clinical candidates.
- 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
- 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, ESPP (Employee Stock Purchase Plan) and stock options.
Sutro Biopharma is committed to the diversity of our team and we are committed to Equal Employment Opportunity without regard for race, ethnicity, gender, protected veteran status, disability, sexual orientation, gender identity or religion.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
Please be advised, inquiries or resumes from recruiters will not be accepted.