Allogene is seeking a Senior Director, CMC Regulatory Affairs to provide support for development and marketed products and provide product strategy and direction to research, clinical, and manufacturing/tech ops teams. Reporting to the Head of Regulatory Affairs, this individual will be responsible for assuring the CMC regulatory strategy is aligned with Health Authority requirements and regulatory submissions are on time and high quality.
Responsibilities include, but are not limited to:
As a member of the project teams, provide strategic CMC regulatory leadership support for multiple innovative Allogeneic CAR T programs.
Provide CMC expertise for global development and registration programs (e.g., INDs, CTAs, NDAs and MAAs)
Primary regulatory representative (for assigned projects) at internal meetings as well as at meetings with regulatory agencies for CMC related issues.
Lead negotiations with regulatory agencies to resolve CMC issues and oversee proactive interactions with regulators globally (US, EU and Japan) for initial INDs/CTAs, marketing registration applications, supplements and variations.
Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines. Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
Responsible for compilation, review, approval and submission of high quality CMC related sections of INDs/CTAs, including responses to questions from various regulatory authorities, working in collaboration with SME’s in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain and other business partners. Maintain responsibility for all CMC Regulatory timelines.
Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
Support interactions with regulatory agencies during inspections
Manage contract staff and vendors as needed to support regulatory activities
Other duties as assigned
Advanced scientific degree preferred in the sciences, or health related field minimum, with a minimum of 12+ years CMC regulatory experience
Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of biologics. Cell Therapy experience would be preferred
Established working knowledge of regulatory guidelines and regulations including Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines (e.g., ICH, FDA and EMA guideline)Regulatory experience supporting both development projects and marketed products including support of post-approval dossier life cycle management
Experience with Orphan Drug Designation, BTD, RMAT, direct interactions supporting health authority GMP inspections desirable is preferred
Strong knowledge of eCTD elements and structure including CMC-regulatory writing skills
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 and drive results
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.
Employer will assist with relocation costs.
Internal Number: CMC
About Allogene Therapeutics
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.