Senior Manager, Regulatory Affairs CMC (South San Francisco, CA)
Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Regulatory 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.
- Responsible for Regulatory Affairs CMC activities for one or more assigned product(s).
- Lead cross-functional teams in planning, development and submission of the CMC dossier, including responses to questions from global regulatory agencies.
- Ensures regulatory documents are of high quality, compliant with current global regulatory requirements and are delivered in a timely manner.
- Maintain CMC dossier per regional requirements and ensure appropriate updates are made per the long-term plan.
- Lead activities for meetings with Health Authorities on CMC related matters.
- Incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams.
- Collaborate with cross-functional teams to identify risks and develop appropriate mitigation strategies.
- Participate in building Regulatory CMC business processes and systems to increase efficiency.
- Evaluate change proposals for global regulatory impact and support planned global variations and amendments.
- Works with regulatory operations to develop submission plans and timelines.
- Support collaboration with internal and external partners (including CROs, CMOs, corporate partners).
- Bachelor’s degree Life/Health Sciences; Master’s degree and/or D. is a plus.
- Minimum of 6+ years of experience in pharmaceutical/biotech with minimum of 4-6 years in CMC Regulatory Affairs for biologics. Prior experience with antibody drug conjugates is preferred.
- Knowledgeable of US and international regulations regarding to CMC aspects of drug and biologic development.
- Experience managing the development of INDs and global clinical trial applications, or equivalent regulatory submission experience.
- Demonstrated ability to work with cross functional teams.
- Prior participation in regulatory agency interactions (e.g., FDA meetings) is preferred.
- Strong technical and analytical skills with the ability to make data-driven decisions.
- Expert written and oral communication skills.
- Domestic or international travel may be required.
Sound exciting? Apply today and join our team!
Please submit resume for Req. #22-700-001N to email@example.com. Please visit our website at www.sutrobio.com for more information.
Sutro Biopharma, Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Sutro will consider requests for reasonable accommodations.
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.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $165,000 – $185,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
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.