Associate Director, CMC Regulatory Affairs
Regulatory Affairs | Hybrid in South San Francisco, CA | Full Time | From $170,000.00 to $210,000.00 per year
Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.
At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
About the role:
The Associate Director, CMC Regulatory Affairs will be responsible for planning and coordination of CMC related regulatory submissions in accordance with applicable regulatory requirements to advance Allogene’s portfolio of allogeneic CAR products. This position will support all regulatory activities to provide high quality CMC sections of regulatory documentation, with a focus on leading ALLO-647 BLA preparation. ALLO-647 is a monoclonal antibody used in combination with our allogeneic CAR T products as part of the lymphodepletion regimen. This individual will also work alongside with the CMC Regulatory leadership to support the CMC aspects of select CAR-T assets within the Allogene portfolio.
Responsibilities include, but are not limited to:
- Working with cross functional team to implement effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks.
- Provide guidance for regulatory CMC aspects of product development projects.
- Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines.
- Support Regulatory team with discussions and interactions with health authorities to facilitate review and approval of submissions.
- Develop regulatory processes and procedures to support CMC components of regulatory submissions.
- Support the creation and maintenance of CMC submission templates.
- Provide CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls.
- Provide interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs.
- Other duties as assigned
Position Requirements & Experience:
- BS/MS or advanced degree in a scientific/engineering discipline or equivalent experience
- Experience in the pharmaceutical/biotech industry
- Prior direct experience with monoclonal antibodies, including BLA submission, preferred
- Knowledge of drug development regulations and guidelines (i.e. FDA, EU and ROW regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices)
- Strong skills in planning, critical thinking and problem-solving
- Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a level of attention to detail
We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $170,000 to $210,000. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.
As an equal opportunity employer, Allogene 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. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.