Manager, Regulatory Affairs

Overview

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 at

Manager, Regulatory Affairs

• Support the regulatory function in assigned projects to drive global regulatory strategy and execution.
• Provide regulatory strategy, guidance, and input throughout product development.
• 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, etc., 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 as needed to support regulatory activities.
• Maintain knowledge of current global regulations and guidance governing drugs and biologics in all phases of development.

• Strong scientific background with BA/BS degree in life sciences, pharmacy, or 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 is desirable.
• Knowledge and experience in interpretation of regulations and guidelines related to drugs.
• The desire and ability to work in a fast-paced, start-up environment.
• Strong collaboration, teamwork, organizational skills, and attention to detail.
• Excellent written and verbal communication.

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 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.