Manager, Regulatory Affairs at Adicet Bio

Redwood City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

31 Dec, 25

Salary

171000.0

Posted On

02 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Cell Therapy Development, Project Management, Regulatory Strategy, Documentation Review, Clinical Compliance, Cross-Functional Collaboration, Communication Skills, Scientific Background, Teamwork, Organizational Skills, Attention to Detail, Quality Assurance, Analytical Testing, Research, GxP Compliance

Industry

Biotechnology Research

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. 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. 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. Key responsibilities: Support the regulatory function in assigned projects to drive global regulatory Provide regulatory strategy, guidance and input throughout product Manage the preparation and filing of regulatory applications, commitments, and change amendments. Author and review regulatory documents to ensure that all submissions are of high Support the preparation and conduct of Agency meetings, including preparation and coordination of briefing packages. Review clinical and CMC documentation, including protocols, reports, DSUR’s, 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 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 Experience in quality assurance, analytical testing, and research is Knowledge and experience in interpretation of regulations and guidelines related to drug The desire and ability to work in a fast-paced, start-up Strong collaboration, teamwork, organizational skills, and attention to 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. 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.

Responsibilities

The Manager will manage the global regulatory implementation of assigned projects in early to late-stage development. They will provide regulatory strategy, guidance, and input throughout product development and ensure timely and robust regulatory submissions.