Senior Director, CMC Regulatory Affairs at Allogene Therapeutics in San Francisco, CA

Job description

About Allogene: 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) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. About the role: Allogene Therapeutics is seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory Affairs and Clinical Quality group to support products under development and lead CMC product strategy and provide regulatory direction to quality, manufacturing/tech ops and supply chain 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. This is a hybrid role based at our headquarters in South San Francisco, CA (US-based, west coast remote may be considered for candidates outside of the area). Responsibilities include, but are not limited to: As a member of the CMC 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, BLAs 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. Position Requirements & Experience: Advanced scientific degree preferred in the sciences, or health related field or equivalent experience CMC regulatory experience in the pharmaceutical/biotech industry Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of Cell Therapy 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 Prior supervisory experience preferred Strong knowledge of eCTD elements and structure including CMC-regulatory writing skills Ability to work in a fast-paced, start-up