Senior Director, CMC Regulatory Affairs

Allogene Therapeutics•South San Francisco, CA

6d•Hybrid

About The Position

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. The position is a hybrid role located in South San Francisco and may be remote up to 2 days per week.

Requirements

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
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.

Nice To Haves

Orphan Drug Designation, BTD, RMAT, direct interactions supporting health authority GMP inspections desirable is preferred
Prior supervisory experience preferred

Responsibilities

Provide strategic CMC regulatory leadership support for multiple innovative Allogeneic CAR T programs as a member of the CMC project teams.
Provide CMC expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs).
Serve as the primary regulatory representative (for assigned projects) at internal meetings and 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 SMEs 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.