Head of Regulatory Affairs at Senti Biosciences
South San Francisco, CA, US
Thank you for your interest in a career at Senti Biosciences. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. We are passionate about designing gene circuits to improve the “intelligence” of cell and gene therapies in order to enhance their therapeutic effectiveness against a broad range of diseases that conventional medicines are unable to address.
 
At Senti, we find purpose and meaning knowing that our efforts have the potential to improve the lives of patients and their families with more effective and safer treatment options. With science as our foundation and empathy as our key guiding principle, colleagues become friends, managers become mentors, and with time, cancer becomes history.
 
Senti is recruiting an experienced Regulatory Affairs leader who will grow a high-performing Regulatory function for a fast-growing biotechnology company. The successful candidate will be accountable for providing strategic regulatory expertise to the Executive team, driving regulatory strategy for overall development of Senti Bio’s cell therapies products, and participating in the development and generation of regulatory submissions to regulatory agencies worldwide. The successful candidate will work to develop the long term regulatory strategy and vision for Senti. This includes leading interactions with health authorities, leading and contributing to submission management activities, and creating fit for purpose regulatory function processes including appropriate build out of the regulatory team. 
The incumbent will oversee all aspects of regulatory activities not limited to preclinical, clinical and manufacturing development, and ensure regulatory compliance with applicable laws, regulations (state, federal, and international), and company policies that govern the development of the company’s products. 

Responsibilites

    • Lead the regulatory function and enable rapid and successful product development, approvals, and life-cycle management
    • Establish the long-term strategy for the regulatory team, activities, and planning in accordance with an established road map, with an expectation to scale-up efficiently and rapidly
    • Grow the regulatory function, and maintain strong leadership capabilities at all levels within the regulatory team and support the professional development of regulatory team members through mentorship and training
    • Maintain current expertise in regulatory trends and operations by ensuring the successful on time delivery of high-quality submissions to global regulatory health authorities in alignment with Senti and health authority standards
    • Oversee the development and implementation of innovative systems, tools and streamlined processes to create and maintain high-quality regulatory submissions and manage a state-of-the-art regulatory intelligence and knowledge management approach
    • Responsible for continuous improvement of systems and processes, including internal training, for the regulatory department and cross functional teams
    • Ensure inspection readiness efforts for regulatory activities and files
    • Provide strategic regulatory oversight and guidance to the Executive and product development teams
    • Advise on regulatory strategies to expedite the development of products
    • Plan and maintain the company’s regulatory applications by spearheading the creation of regulatory applications (Pre-IND, IND, and BLA), including authorship of key regulatory documents, as necessary
    • Review and provide oversight of all critical regulatory submissions, risk assessment, ensuring compliance with applicable laws and regulations
    • Serve as primary interface with FDA and other regulatory authorities for high impact topics, technical discussions and collaborate with corresponding groups at Health Authorities to advance Regulatory Science
    • Reviews all planning, budgeting, staffing, and prioritization for the department
    • Maintain positive work environment with colleagues and external partners

Qualifications

    • Minimum 10-15 years in pharmaceutical / biopharmaceutical industry (ideally both small and large companies)
    • Extensive regulatory management experience and in developing innovative regulatory solutions
    • Experience with oncology products, cell and gene therapy products/ complex biological products
    • Relevant knowledge in CMC, clinical and nonclinical science
    • Knowledge expert regarding global cell therapy product development guidelines, regulatory submission standards and publishing best practices
    • Thorough understanding of relevant drug development regulations and guidelines
    • Experience with process design and improvement and with developing systems from the ground up
    • Ability to critically evaluate opportunities and assess and articulate risks to enable corporate decisions
    • Ability and interest in rolling up their sleeves to perform hands-on regulatory activities while simultaneously building the department and/ or working with external consultant(s) to ensure successful scalability as the programs grow
    • Excellent verbal and written communication skills with an ability to communicate across a variety of audiences including team members, cross-functional project teams, leaders, and senior management and external agencies
    • Demonstrated ability to work on complex problems and business processes in which the analysis of situations and/or data frequently requires an in-depth evaluation of multiple, interdependent factors and professional judgment
    • Candidates must have substantial relevant experience in all aspects of regulatory affairs, with a track record of successful and direct interfacing with FDA CBER OTAT office
    • Hands-on experience and knowledge in authoring, compiling, reviewing, and managing major regulatory submissions (Pre-INDs, INDs, BLAs)
    • History of achieving regulatory goals in ambiguous and challenging situations
    • Demonstrate strong organizational skills, including the ability to prioritize workload

Salary and Benefits

      • Base pay and stock options to be determined based on application qualifications with the aim of being competitive with similar roles in the area
      • Significant growth opportunity as the company expands
      • Empathetic, supportive and collaborative colleagues and work environment
 
Senti Bio is a leading gene circuit company designing gene circuits to create a new generation of “smarter medicines" and enhance the therapeutic effectiveness of cell and gene therapies against a broad range of diseases that are unaddressed by current standards of care. We are proud to count Leaps by Bayer, NEA, 8VC, Matrix Partners China, Mirae Asset Capital, Amgen Ventures, and others among our investors. In December 2021, Senti Bio and Dynamics Special Purpose Corp. (Nasdaq: DYNS), a special purpose acquisition company (SPAC), announced a definitive business combination agreement to create a public company focused on Gene Circuit-engineered cell and gene therapies. The transaction is expected to be completed in the second quarter of 2022. Senti Bio is based in South San Francisco, CA, USA.
 
We are committed to an inclusive and diverse Senti Bio. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse Senti Team. We welcome people of different backgrounds, experiences, abilities and perspectives and are an equal opportunity employer.