South San Francisco, California, United States · Hybrid
$245k–$285k/yr
The successful candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading regulatory CMC strategies and activities for a complex cell therapy p…
Skills: Regulatory CMC Strategy, Cell Therapy, Gene Therapy, IND/BLA/CTA/MAA Submissions, Agency Interactions
South San Francisco, California, United States • Hybrid
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Lead and manage global regulatory CMC strategies and activities for complex cell therapy products. Oversee the preparation and filing of regulatory submissions while serving as the primary point of contact for cross-functional teams and agencies.
Requires a BA/BS in a scientific field with over 10 years of regulatory experience in the pharmaceutical or biotech industry. Strong expertise in biologics drug development and experience with gene or cell therapy is preferred.
The successful candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading regulatory CMC strategies and activities for a complex cell therapy product on a global basis. The successful candidate 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. Familiarity with GMP Quality, CMC development and exposure to clinical regulatory strategy is highly desired. (***For the potential candidate at VP level direct report possibilities)
\nResponsibilitiesOutsmarting complex diseases with more intelligent medicines
Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. To accomplish this mission, we are building a synthetic biology platform that could enable us to program next-generation cell and gene therapies with what we refer to as “gene circuits”. These gene circuits, which are created from novel and proprietary combinations of DNA sequences, are intended to reprogram cells with biological logic to sense inputs, compute decisions and respond to their cellular environments. We are 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 do not readily address. For more information, please visit the Senti Bio website at https://www.sentibio.com.
Offices: 2 Corporate Drive, First Floor, South San Francisco, CA 94080, US
Outsmarting complex diseases with more intelligent medicines
Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. To accomplish this mission, we are building a synthetic biology platform that could enable us to program next-generation cell and gene therapies with what we refer to as “gene circuits”. These gene circuits, which are created from novel and proprietary combinations of DNA sequences, are intended to reprogram cells with biological logic to sense inputs, compute decisions and respond to their cellular environments. We are 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 do not readily address. For more information, please visit the Senti Bio website at https://www.sentibio.com.
Offices: 2 Corporate Drive, First Floor, South San Francisco, CA 94080, US
