Senior Director, CMC Regulatory Affairs

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.

Responsibilities

• 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.