Associate Director / Director, Regulatory Affairs

Company: Adicet Bio, Inc.
Location: Redwood City
Posted on: March 19, 2023

Job Description:

Associate Director Director Regulatory Affairs - Careers At Adicet Bio Back To Openings Associate Director / Director, Regulatory Affairs Department: Regulatory Location: Redwood City, CA
START YOUR APPLICATION JOIN US! Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs) and adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients. For more information, please visit our website at https://www.adicetbio.com . ASSOCIATE DIRECTOR / DIRECTOR, REGULATORY AFFAIRS Adicet Bio is seeking an exceptionally talented and motivated individual to join our team as Associate Director/Director, Regulatory Affairs. This position will be responsible for developing and executing innovative regulatory strategies in support of the nonclinical and clinical development for our early development pipeline products within the Regulatory Affairs department. In this lead, direct role, the successful candidate will provide dynamic leadership and direction to senior management and product development teams and will work in close partnership with the nonclinical and clinical leadership to achieve development milestones in an efficient and compliant manner. The role would require a strong scientific background with understanding and experience in GLP, GCP, and relevant regulatory guidelines to contribute to and shape the overall clinical development strategy. The successful candidate will interface cross-functionally in a matrixed environment to integrate nonclinical and clinical plans with overall development plans and ensure planning, coordination, and communication to develop timely and robust regulatory strategies and submissions to meet overall program objectives/milestones. Key responsibilities:

• Manage all aspects of nonclinical and clinical regulatory strategy development for Adicet products (early- to late-stage/registration/post-market).
• Lead teams in examining regulatory strategy options, provide relevant regulatory guidance.
• Identify and assess regulatory risks and critical-path activities associated with nonclinical and clinical development programs and work to identify regulatory strategies to mitigate risks.
• Monitor and analyze regulatory agency activities regarding nonclinical and clinical development and assess potential impact on the Adicet development programs and understand the regulatory landscape.
• Serve as Regulatory Lead on cross functional project teams to achieve project milestones/goals.
• Lead global regulatory submission development - Responsible for planning, coordinating, and developing high quality, compliant and timely regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, BLA/MAA, pre-meeting briefing documents, etc.).
• Assist in organization and management of staff within the RA group, including coaching, career development and oversight of work, as required. Qualifications:
  • Master's degree in life sciences, or advanced degree preferred.
  • Prior experience with cell or gene therapies
  • Prior experience in oncology drug development
  • 10+ years working within the biotech/pharmaceutical industry. 8+ years of pharma and/or biotech regulatory CMC-experience.
  • Depth Knowledge of GLP and GCP regulatory requirements in domestic and globally.
  • Ability to lead matrixed teams, drive and influence effective collaborations.
  • Strong scientific writing and oral communication skills with ability to summarize clearly and succinctly and tailor messaging to target audience.
  • Initiative-taking, self-disciplined, and able to function independently as well as part of a team.
  • Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc. Adicet Bio requires all workers to be fully vaccinated against COVID-19, including the booster dose. 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 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 12 company holidays with end-of-year shutdown, 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, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms. In compliance with California's pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $165,000.00 - $250,000.00 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting. START YOUR APPLICATION

Keywords: Adicet Bio, Inc., Redwood City , Associate Director / Director, Regulatory Affairs, Executive , Redwood City, California