Director, CMC Regulatory Affairs
Regulatory Affairs | South San Francisco, CA | Full Time
Allogene Therapeutics is a biotechnology company with a mission to catalyze the next revolution in cancer treatment through the development of allogeneic chimeric antigen receptor T-cell (CAR T) therapy directed at blood cancers and solid tumors. Founded and led by former Kite Pharma executives who bring unrivaled clinical development acumen in cell therapy, Allogene is well-positioned to further the potential of allogeneic cell therapy for patients.
Allogeneic CAR T therapies are engineered from cells of healthy donors and stored for “off-the-shelf” use in patients. This approach eliminates the need to create personalized therapy from a patient’s own cells, simplifies manufacturing, and reduces the time patients must wait for CAR T treatment. The Allogene portfolio includes 16 pre-clinical T cell therapy assets and UCART19, an allogeneic CAR T therapy currently in Phase 1 development for the treatment of acute lymphoblastic leukemia (ALL). Through its notable partnerships, Allogene leverages pioneering technology platforms, including TALEN® gene editing technology, to progress its portfolio of immuno-oncology therapies. Allogene, with headquarters in South San Francisco, California, is a Two River portfolio company formed with one of the largest Series A financings in biotechnology from an investment consortium which includes TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer, and Pfizer. For more information, please visit: www.allogene.com, follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a Director of Regulatory 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
- 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 a minimum of 10+ years CMC regulatory experience
- 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.
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.