Director, Regulatory Affairs CMC
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.
The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.
Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Chemistry, Manufacturing, and Control team as we change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing our technology and progressing our novel therapeutics. We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.
- Provides strong regulatory and scientific leadership to the cross-functional development teams to ensure that the development plan provides optimal scientific positioning and the highest regulatory probability of success
- Directs the preparation, review, and planning of CMC submissions to regulatory agencies like FDA, EMA, and other global Health Authorities to support the conduct of clinical trials, and approval of marketing applications, while being responsible for the maintenance of these applications (INDs, CTAs, DMFs, BLAs, MAAs).
- Ensures regulatory documents are high quality, delivered in a timely manner, consistent with corporate strategy, and compliant with current global regulatory requirements.
- Leads communication with Health Agencies on all CMC issues.
- Facilitates preparation of briefing materials, responses to Health Authority questions, anticipates issues, and provides guidance to cross-functional teams on risk mitigation strategies with respect to CMC topics.
- Works with regulatory operations to develop submission plans and timelines.
- Incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams.
- Bachelor’s degree Life/Health Sciences; Master’s degree and/or Ph.D. is a plus.
- Minimum of 8-10 years of experience in pharmaceutical/biotech with minimum of 6-8 years in CMC Regulatory Affairs.
- Knowledgeable of US and international regulations regarding to CMC aspects of drug and biologic development with an understanding of expedited approval pathways.
- Demonstrates experience managing the development of INDs and global clinical trial applications as well as BLAs/MAAs.
- Experience leading regulatory agency interactions (FDA meetings, EMA Scientific Advice, Advisory Committees, Oral Explanations, etc.)
- Strong technical and analytical skills with the ability to make data-driven decisions.
- Expert written and oral communication skills.
- Robust leadership, negotiation, and collaboration skills.
- Proficient at creating and communicating a clear vision among team member by effectively aligning resources and activities to achieve organizational goals.
- Experience leading regulatory agency interactions on complex CMC/technical topics.
Sound exciting? Apply today and join our team!
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.
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.
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.