Manager, Regulatory Affairs

<div class="content-intro"><p><strong>JOIN US!</strong></p> <p>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 <a href="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">https://www.adicetbio.com</a>.</p></div><p><strong>Manager, Regulatory Affairs</strong></p> <p>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.</p> <p>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.</p> <p> </p> <p><strong><em>Key responsibilities:</em></strong></p> <ul> <li>Support the regulatory CMC functions in assigned project(s) to drive global regulatory timelines and milestones throughout the lifecycle of product development.</li> <li>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</li> <li>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.</li> <li>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.</li> <li>Assist in maintenance and tracking of company databases, including regulatory submissions, agency communications, commitments, agency information requests and responses, etc.</li> <li>Interface with functional areas, external partners and consultants, as</li> <li>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</li> </ul> <p>teams.</p> <ul> <li>Opportunity to develop publishing skills related to submission of electronic CTD compliant documentation.</li> </ul> <p> </p> <p><strong><em>Qualifications:</em></strong></p> <ul> <li>Experienced in FDA and/or ex-US submissions.</li> <li>Understand the general requirements of INDs, CTAs, DMFs, ARs/DSURs, FT/RMAT/BTD, and amendments.</li> <li>Strong scientific background with BA/BS degree in life sciences, pharmacy, or other related fields. Advanced degree is preferred.</li> <li>At least eight years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry, with five years of Reg