Senior Director, Regulatory Affairs - CMC

Company: Adicet Bio, Inc.
Location: Redwood City
Posted on: January 21, 2023

Job Description:

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 . SENIOR DIRECTOR, REGULATORY AFFAIRS - CMC Adicet Bio is seeking an exceptionally talented and motivated individual to join our team as Senior Director, Regulatory Affairs (CMC). This position will be responsible for developing and executing innovative regulatory strategies in support of the chemistry, manufacturing, and controls (CMC) 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 CMC/Quality leadership to achieve development milestones in an efficient and compliant manner. The role would require a strong scientific background with understanding and experience in cGMP manufacturing, analytical practices, and relevant regulatory guidelines to contribute to and shape the overall manufacturing strategy. The successful candidate will interface cross-functionally in a matrixed environment to integrate CMC 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:

• Lead and manage all aspects of CMC 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 CMC development programs and work to identify regulatory strategies to mitigate risks.
• Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on the Adicet development programs and understand the regulatory landscape.
• Evaluate proposed manufacturing changes for global impact and provide strategic regulatory strategies that support compliant change implementation.
• Serve as CMC Regulatory Lead on cross functional project teams to achieve project milestones/goals.
• Serve as the Regulatory point of contact for Contract Manufacturing Organizations and Qualified Persons.
• Lead global CMC regulatory submission development - Responsible for planning, coordinating, and developing high quality, compliant and timely CMC (Quality) 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:
  • Bachelor's degree (or equivalent) in life sciences, masters or advanced degree preferred.
  • Prior experience with cell or gene therapies
  • 10+ years working within the biotech/pharmaceutical industry. 8+ years of pharma and/or biotech regulatory CMC-experience.
  • Depth Knowledge of cGMP, CMC regulatory requirements in domestric 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 $217,000 - $299,000 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.

Keywords: Adicet Bio, Inc., Redwood City , Senior Director, Regulatory Affairs - CMC, Executive , Redwood City, California