Associate Director, Regulatory Affairs

Allogene - South San Francisco, CA

Full-time
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a world-class management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy faster, more reliably and at greater scale to more patients.

AlloCAR T™ cell therapies are engineered from cells of healthy donors, which is intended to allow for creation of inventory for on demand use in patients. This approach is designed to eliminate the need to create personalized therapy from a patient’s own cells, simplify manufacturing, and reduce the time patients must wait for CAR T cell treatment. The Allogene portfolio includes rights to 16 pre-clinical CAR T cell therapy targets and UCART19, an AlloCAR T™ therapy candidate currently in Phase 1 sponsored by Servier for the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL). For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

Allogene is seeking a Director of Regulatory Affairs within the Regulatory Strategy group who will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products. This individual will be a key member of project teams and teams responsible for evaluation of product concepts. Reporting to the Head of Regulatory Affairs, this individual will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements and regulatory submissions are on time and of high quality.

Responsibilities include, but are not limited to:
  • Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development. As a member of the project teams, provide strategic regulatory guidance for global development and registration programs (e.g., INDs, CTAs, NDAs and MAAs)
  • Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines. Maintain awareness of and communicate changing regulatory agency requirements; provide training and regulatory intelligence to the organization
  • Develops overall timelines and plans by working with team members in research and development, QA, Clinical Operations and Clinical Affairs to ensure regulatory requirements are properly covered and implemented as part of product development plans. Primary regulatory representative (for assigned projects) at internal meetings as well as at meetings with regulatory agencies for all clinical related issues
  • Ensure the timely submission of INDs, BLAs, amendments, and supplements for assigned products/projects
  • Respond to regulatory questions from various regulatory authorities, working in collaboration with SME’s in Research, Clinical, Nonclinical and other business partners
  • Oversees and manages regulatory documentation infrastructure, including e-submissions.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports
  • Manage contract staff and vendors as needed to support regulatory activities
  • Other duties as assigned
Requirements:
  • Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of Cell Therapy
  • Advanced scientific degree preferred in the sciences, or health related field minimum, with 10+ years regulatory experience
  • Established working knowledge of regulatory guidelines and regulations (US and international)
  • Regulatory experience supporting both development projects and marketed products
  • First-hand knowledge and experience of interactions with FDA is preferred
  • Experience with Orphan Drug Designation, BTD and RMAT is preferred
  • Strong knowledge of eCTD elements and structure and regulatory writing skills
  • Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
  • Ability to work in a fast-paced, start-up environment
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
  • Ability to work independently and as part of a team
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
  • Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.