Manager, Regulatory Affairs

Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website

Adicet Bio is seeking a highly motivated Manager, Regulatory Affairs, who is passionate in the field of cell therapy development for oncology and autoimmune patients. He/she is a curious learner, dedicated, highly focused, and welcomes unexpected challenges. The desired candidate must be a team player and enjoy a fast-paced, dynamic work environment.

The Manager will report into the Regulatory group devoted to developing regulatory strategies that support rapid clinical and product development of cell therapies. He/she will be responsible for managing the global regulatory implementation of assigned projects in early to late-stage development. The successful candidate will interface cross-functionally in a matrixed environment to ensure planning, coordination, and communication for development of timely and robust regulatory strategies and submissions to meet overall program objectives/milestones.

• Support the regulatory function in assigned projects to drive global regulatory strategy and guidance.
• Provide regulatory strategy, guidance and input throughout product lifecycle.
• Manage the preparation and filing of regulatory applications, commitments, and change amendments. Author and review regulatory documents to ensure submissions are of high quality.
• Support the preparation and conduct of Agency meetings, including preparation and coordination of briefing packages.
• Review clinical and CMC documentation, including protocols, reports, DSURs, Investigator Brochures, change controls, certificates of analyses, to ensure GxP and regulatory compliance.
• Create and maintain regulatory timelines and track deliverables to ensure submission timelines are met for assigned projects.
• Interface with functional areas, external partners and consultants.
• Maintain knowledge of current global regulations and guidance governing drugs and biologics in all phases of development.

Qualifications:

• Strong scientific background with BA/BS degree in life sciences, pharmacy, or other related fields. Advanced degree is preferred.
• At least five years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry.
• Experience in quality assurance, analytical testing, and research.
• Knowledge and experience in interpretation of regulations and guidelines related to drug development.
• The desire and ability to work in a fast-paced, start-up environment.
• Strong collaboration, teamwork, organizational skills, and attention to detail.

Pay Range

$124,000 - $171,000 USD

Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite at least three days per week (Tuesday–Thursday mandatory), with some roles requiring full-time onsite presence.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.