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 at .

Adicet Bio is seeking a highly motivated Manager, Regulatory Affairs who is passionate about cell therapy development for oncology and autoimmune patients. The Manager will report into the Regulatory group devoted to developing regulatory strategies that support rapid clinical and product development of cell therapies. The Manager will manage the global regulatory implementation of assigned projects in early to late‑stage development and 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 execution.
• Provide regulatory strategy, guidance, and input throughout product lifecycle phases.
• Manage the preparation and filing of regulatory applications, commitments, and change amendments; author and review regulatory documents to ensure all submissions are high quality and compliant.
• 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 to support regulatory strategy and execution.
• 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 field; advanced degree 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 drug and biologic development.
• 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 skills.

Pay Range: $124,000—$171,000 USD.

Adicet offers a competitive compensation package including base salary, annual cash bonus, long‑term incentives (equity), Employee Stock Purchase Plan (ESPP), and a 401(k) with ROTH and a 4.5% company match. We also offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company‑matched Health Savings Account (HSA); life, AD&D, short and long‑term disability insurance;

and legal, pet, and various other voluntary insurance programs. Generous paid time‑off includes 13 company holidays, paid end‑of‑year winter break, vacation, sick time, and paid parental leave.

Adicet fosters a collaborative, high‑performing environment prioritizing in‑person engagement. 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 identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.