Associate Director, Regulatory Affairs

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 is seeking an Associate Director Regulatory Affairs within the Global Regulatory Affairs and Clinical Quality organization who will manage worldwide interactions and negotiations with regulatory agencies and development partners in support of investigational studies and marketing authorizations. This individual will play a key role in defining and executing regulatory strategy managing global regulatory submissions and contributing to regulatory intelligence activities across Allogenes pipeline. Reporting to the Senior Director Regulatory Affairs this position will serve as a core regulatory representative on crossfunctional program teams supporting interactions with global health authorities and ensuring regulatory strategies and submissions are aligned with evolving regulatory expectations for cell and gene therapies. This is a hybrid role based at our headquarters in South San Francisco CA (US based remote may be considered as well for candidates outside of the area).

Responsibilities include but are not limited to:

• Serve as a regulatory affairs lead on assigned clinical studies supporting the development and execution of global clinical regulatory strategies
• Lead cross-functional teams in the planning preparation and maintenance of global regulatory submissions including INDs CTAs protocol amendments IBs annual reports safety updates and other clinical regulatory filings
• Lead and/or support interactions with global regulatory agencies (FDA EMA Health Canada and others) including preparation of meeting requests background packages responses and questions and followup correspondence
• Manage preparation and coordination of responses to global regulatory authority information requests related to clinical development activities
• Partner closely with cross-functional teams to ensure regulatory requirements are integrated into study design and execution
• Track regulatory timelines and deliverables to ensure submissions are completed on time and to a high standard of quality
• Support regulatory strategy considerations related to accelerated programs (e.g. Fast Track BTD RMAT PRIME Orphan Drug Designation) as applicable
• Support regulatory strategy considerations related to companion diagnostics (CDx) and in vitro diagnostic (IVD) development as applicable to clinical programs and global regulatory submissions
• Assist in the development and maintenance of internal regulatory processes templates and best practices
• Manage and coordinate activities with external vendors consultants and contract resources located globally to support regulatory activities and Health Authority interactions
• Escalate regulatory risks and issues to management with proposed mitigation strategies
• Monitor interpret and communicate global regulatory intelligence relevant to cell therapy clinical development including evolving guidance precedents and expedited development programs
• Other duties as assigned

Position Requirements & Experience:

• Bachelors degree in biological pharmaceutical chemical or related scientific discipline required; advanced degree preferred with at least 7 years of regulatory affairs experience within the biotechnology or pharmaceutical industry including direct involvement in clinicalstage regulatory activities
• Demonstrated working knowledge of FDA EMA and other global health authority regulations applicable to clinical development
• Handson experience preparing and/or managing INDs CTAs and clinical regulatory submissions across multiple regions
• Experience supporting regulatory strategy for early and midstage clinical development programs
• Prior experience in cell therapy gene therapy or other advanced therapy medicinal products (ATMPs) is highly preferred
• Experience with regulatory considerations for CDx and IVD development including coordination of drugdiagnostic development activities is a plus
• Familiarity with eCTD structure and regulatory document authoring requirements
• Ability to work effectively in a fastpaced matrixed environment while managing multiple priorities
• Strong written and verbal communication skills with the ability to clearly convey regulatory considerations to crossfunctional stakeholders
• Strong organizational skills attention to detail and ability to independently drive deliverables to completion
• Candidates must be authorized to work in the United States

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 $170000 - $210000 per year. 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 designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.