Senior Manager, Regulatory affairs

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 a Senior Manager 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.

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 points 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.

Qualifications:

• 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

• Officebasedpositionwithsometravel(domesticandinternational),upto25%.

Sound exciting? Apply today and join our team!

Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment.

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.

To recruiting firms: Sutro Biopharma does not accept agency resumes and solicitations from third-party agencies. Please do not forward resumes to our hiring managers or employees. Sutro Biopharma is not responsible for any fees related to unsolicited resumes.

The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $153,000 - $175,000 (not including bonus, equity, and benefits). The base salary offered will vary depending on the market, job-related knowledge, skills and capabilities, and experience.

About Sutro Biopharma

Sutro Biopharma, Inc., is relentlessly focused on the discovery and development of precisely designed cancer therapeutics to transform what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro is advancing a robust early-stage pipeline of novel exatecan and dual-payload antibody drug conjugates (ADCs), coupled with high-value collaborations and industry partnerships, which validate its continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com