Manager, Regulatory Affairs

About the role

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.

Adicet is seeking a highly motivated Manager, Regulatory Affairs, who is passionate in the field of cell therapy development for oncology and autoimmune patients. 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.

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 quality.
• 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 needed.
• 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 a plus.

Role-related Competencies

• Able to facilitate/impact and influence effective planning interactions and discussions.
• Able to effectively interact with external parties to gather information 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, offering 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.

Schedule

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

Pay Range: $130,000 – $179,000 USD

Benefits

• 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.
• 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 including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave.
• 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.