--- title: 'Manager, Regulatory Affairs at Adicet Bio' canonical: 'https://feeny.ai/job/manager-regulatory-affairs-adicet-bio-redwood-city-8agd1nr4zgj0' type: 'job' last_seen: '2026-09-11' --- # Manager, Regulatory Affairs at Adicet Bio - **Company:** Adicet Bio - **Location:** Redwood City, CA - **Compensation:** $130k–$179k - **Posted:** 2026-08-27 - **Last confirmed live:** 2026-09-11 - **Apply:** https://boards.greenhouse.io/adicettherapeuticsinc/jobs/5223277007?gh_jid=5223277007 ## Job description JOIN US! 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 [https://www.adicetbio.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.adicetbio.com&esheet=54175567&newsitemid=20250108585728&lan=en-US&anchor=https%3A%2F%2Fwww.adicetbio.com&index=1&md5=9d942dbcdb299f0c9fe719a48148cd0e). Manager, Regulatory Affairs 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. They are curious learner, dedicated, highly focused, and welcome unexpected challenges. The desired candidate must enjoy a fast-paced, dynamic, and interactive 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. They will be primarily responsible for managing the global CMC regulatory implementation of assigned projects in early to late-stage development, with additional responsibility to support the implementation of other regulatory activities, including clinical and nonclinical submissions. Key responsibilities: - Support the regulatory CMC functions in assigned project(s) to drive global regulatory timelines and milestones throughout the lifecycle of product development. - Manage the preparation and filing of regulatory CMC submissions, commitments, and change amendments. Author and review regulatory CMC documents to ensure that all submissions are of high - Assist senior RA staff in the development of Meeting Requests, Briefing Books and meeting materials for FDA and ex-US regulatory agency meetings, including pre-IND meetings, End of Phase meetings, Scientific Advice, etc. - Review CMC, clinical, and nonclinical documentation, including change controls, certificates of analyses, labels, study reports, clinical protocols, DSURs, Investigator Brochures, to ensure GxP and regulatory compliance. - Assist in maintenance and tracking of company databases, including regulatory submissions, agency communications, commitments, agency information requests and responses, etc. - Interface with functional areas, external partners and consultants, as - Maintain knowledge of current global regulations and guidance governing drugs and biologics in all phases of development and communicate changes in regulatory information to cross-functional teams. - Opportunity to develop publishing skills related to submission of electronic CTD compliant documentation. Qualifications: - Experienced in FDA and/or ex-US submissions. - Understand the general requirements of INDs, CTAs, DMFs, ARs/DSURs, FT/RMAT/BTD, and amendments. - Strong scientific background with BA/BS degree in life sciences, pharmacy, or other related fields. Advanced degree is preferred. - At least eight years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry, with five years of Regulatory CMC experience. - Previous experience in quality assurance, analytical testing, manufacturing, and research is Key role-related competencies: - Able to facilitate/impact and influence effective planning interactions and discussions. - Able to effectively interact with external parties to information gather and effectively drive projects through to completion to tight timelines. - A good scientific background and understanding with the ability to acquire this knowledge in a short timeframe. Core competencies: - Knowledge of Statutory Framework and Guidance procedures followed by FDA/EMA. - Understanding of product development. - Strong verbal and written communication skills. - Must have strong working knowledge of Microsoft Office and other PC-related applications. - Must take initiative and have ability to work independently and as a team member, offer - assistance wherever needed. - Excellent oral and written English communication skills. - Excellent planning and organizational skills with the ability to work simultaneously on multiple projects with tight timelines. - Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills. - Planning and information seeking skills and ability to work on specific tasks with minimal supervision. - Problem solving, strategic thinking skills with ability to impact and influence. - Attention to detail with accuracy and quality. - Ability to understand and effectively relate to external and internal customers. - Business awareness and professionalism. 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. Pay Range $130,000—$179,000 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. At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting autoimmune diseases and cancer. We offer 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. To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs. We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave. 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. ## About Adicet Bio ## Company Overview - **One-liner**: Adicet Bio is a clinical-stage biotechnology company developing allogeneic, “off-the-shelf” gamma delta T cell therapies for autoimmune diseases and cancer. - **Entity Type**: Public (Ticker: ACET) - **Headquarters**: Redwood City, California, USA (with additional offices in Boston, Massachusetts, USA, and Shanghai, China) - **Founded**: 2015 - **Founders**: Not publicly available (the company originated from the merger of two early-stage biotechs) ## Core Business - **Primary industries**: Biotechnology, Cell Therapy, Immuno-oncology, Autoimmune Therapeutics - **Target customers**: B2B – primarily partners with hospitals, clinical research sites, and eventually healthcare providers for treatment administration; ultimately serves patients with cancer and autoimmune diseases - **Mission statement**: “To deliver best-in-class gamma delta T cell therapies for patients fighting autoimmune diseases & cancer” ## Products & Services - **Prulacabtagene leucel (prula-cel, formerly ADI-001)**: A first-in-class investigational allogeneic gamma delta 1 CAR T cell therapy, currently in Phase 1 clinical trials for lupus nephritis, systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy, stiff person syndrome, ANCA-associated vasculitis, and treatment-refractory rheumatoid arthritis. (Cellular therapy – CAR T, allogeneic/off-the-shelf) - **Pipeline Programs**: Additional gamma delta T cell therapy programs in discovery and preclinical development for autoimmune diseases and cancer, with a target of one new IND filing every 12–18 months. ## Market Standing - **Valuation/Market Cap**: Not publicly available for the most recent date (publicly traded, market cap fluctuates; check latest trading data) - **Key Metric**: Public company; financial results are reported quarterly. As of the most recent filings (Q1 2026 and Full Year 2025), the company is pre-revenue, investing heavily in R&D. - **Notable Investors/Partners**: Adicet Bio’s investor base includes institutional healthcare investors (details available in SEC filings). The company has presented at major healthcare conferences (e.g., Jefferies Global Healthcare Conference). - **Growth Signals**: The company is advancing a multi-indication Phase 1 program for prula-cel, targeting seven autoimmune indications simultaneously. They are also building a pipeline with a cadence of one new IND every 12–18 months. The company has active operations across three U.S. sites (Redwood City, Boston) and Shanghai, China. ## Competitive Advantages - **Gamma Delta 1 T cell platform**: Adicet is a leader in harnessing gamma delta 1 T cells for allogeneic (off-the-shelf) therapy. These cells have an inherent ability to target tissues and kill cells through multiple mechanisms, potentially offering advantages over conventional alpha beta T-cell therapies. - **Off-the-shelf approach**: By using cells from healthy donors (allogeneic), Adicet’s therapies can be “off-the-shelf” and readily available—potentially faster and more scalable than patient-derived (autologous) CAR T therapies. - **Dual therapeutic focus**: The company is uniquely positioned with a pipeline targeting both autoimmune diseases (a rapidly growing cell therapy frontier) and oncology, leveraging the same platform. ## Strategic Focus - **Near-term**: Drive the Phase 1 clinical program for prula-cel across multiple autoimmune indications, with an emphasis on generating proof-of-concept data and advancing toward registrational trials. - **Pipeline expansion**: Continue to file a new IND every 12–18 months, expanding into new indications with additional gamma delta cell therapy candidates. - **Platform and manufacturing**: Advance the allogeneic gamma delta platform and manufacturing process to ensure scalability and consistent product quality for future commercial supply. ## Why Work Here - **Mission-driven**: The company’s core mission is focused on delivering potentially curative therapies for patients with serious autoimmune diseases and cancer, offering a strong sense of purpose. - **Values**: Culture built on Collaboration, Innovation, Courage, Excellence, Appreciation, and Development. The company explicitly includes “Develop” as a value, emphasizing employee growth. - **Compensation & Benefits**: Competitive base salary, annual cash bonuses, long-term incentives (stock options), an Employee Stock Purchase Plan (ESPP), and a 401(k) with ROTH option and a 4.5% company match. - **Work-life & Wellness**: Generous paid time off, including 17 company holidays with an end-of-year shutdown, vacation, sick time, and paid parental leave. Onsite gym, free parking with EV charging, free Caltrain shuttle, daily catered lunches, and fully stocked breakrooms. - **Learning & Development**: Educational reimbursement program up to $4,000 per calendar year and access to a curated LinkedIn Learning curriculum. - **Work Model**: Mixed. Positions are listed as on-site at the Redwood City headquarters for most R&D and leadership roles. - **Team & Environment**: Described as a state-of-the-art facility with a collaborative, highly focused team of scientists and biotech professionals. The company emphasizes attracting and retaining top talent in the cell therapy space. ## Sources 1. [adicetbio.com](https://www.adicetbio.com/) 2. [adicetbio.com/careers](https://www.adicetbio.com/careers/overview/) 3. [adicetbio.com/careers/openings](https://www.adicetbio.com/careers/openings/) 4. [adicetbio.com/about](https://www.adicetbio.com/about/) 5. [investor.adicetbio.com](https://investor.adicetbio.com/investors) ## Other roles at Adicet Bio - [Director/Sr. Director Program Management](https://feeny.ai/job/director-sr-director-program-management-adicet-bio-redwood-city-vzgzddgtmy8q) — Redwood City, CA - [Director, Quality Assurance Operations](https://feeny.ai/job/director-quality-assurance-operations-adicet-bio-redwood-city-nvk46p4m8tzn) — Redwood City, CA - [SR. 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