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.Summary:
The Director/Sr. Director, Regulatory CMC will be responsible for leading and managing the regulatory affairs CMC function. This includes developing and leading regulatory CMC strategies and activities for the organization on a global basis. The Senior Director will ensure that all CMC regulatory goals are clearly defined and they align with current industry standards and regulatory requirements. This role will also provide significant input on applicable regulatory affairs processes, procedures, and tools to facilitate effective execution by the regulatory function across the organization. This individual must be highly skilled and provide expertise in CMC agency interactions and developing regional regulatory CMC strategies. In addition, the position assists corporate senior management in understanding CMC Regulatory strategies/processes while developing corporate objectives and, importantly, understanding the impact of decisions across therapeutic areas.Responsibilities:
- Develop the CMC regulatory strategies and manage related regulatory activities. Work with the Pharmaceutical Development team to prepare project plans and timelines for pipeline of products, including coordination and oversight of all types of regulatory CMC submissions.
- Supervises/manages others to ensure that all reporting requirements and other commitments are met with respect to INDs, BLAs, CTA, MAAs, etc
- Advise the global regulatory compliance of Senti’s Gene Therapy’s pipeline of products including the evaluation of CMC related change controls, the strategic assessment of process and product comparability, their regulatory impact and implementation
- Lead the preparation, review and filing of CMC sections of regulatory submissions and interactions with regulatory agencies
- Oversee, coordinate and ensure the preparation of regulatory CMC submission documentation is prepared with quality and in a timely manner to meet all agency requirements and corporate objectives
- Maintain a centralized archive for tracking and monitoring the status of regulatory CMC commitments and agency reporting obligations. Create and issue status reports and other communication to the organization
- Provide strategic CMC regulatory support, guidance and expertise, and act as the Regulatory Affairs primary point of contact to cross-functional teams including Pharmaceutical Development, Quality Assurance, Quality Control, contract organizations and consultants
- Ensure that all applicable regulatory requirements/options and associated risks are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines
- Work across functional groups in identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as support the resolution of issues that arise
- Ensure the regulatory conformance of technical documentation including technical transfer protocols, validation protocols, technical reports, manufacturing and labeling information
- Provide guidance and advice on regulatory CMC environments; provide assessment of the impact of new and changing regulations/requirements
- Support other Regulatory Affairs functions as needed
Salary and Benefits:
- BA/BS in a scientific field of study with 12 years + of relevant experience working in Regulatory in the pharmaceutical/ biotech industry
- Strong knowledge, experience and leadership in interpretation of regulations and guidelines related to biologics drug development
- Experience in the gene or cell therapy area preferred
- Proven ability to analyze and organize information logically
- In depth understanding and application of industry standards and international regulations and guidelines
- Experience in communicating regulatory strategy, submission documents and plans both internally and externally
- The ability to coordinate and prioritize multiple projects in a fast-paced, deadline driven start-up environment
- Strong collaboration, team work, organizational skills at attention to detail
- Excellent written and verbal communication skills
- Travel 20%
- 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 publicly traded (Nasdaq: SNTI) gene circuit company headquartered in South San Francisco. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches.
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.