Associate Director, Regulatory Affairs
Job Description
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 Allogene's pipeline. Reporting to the Senior Director, Regulatory Affairs, this position will serve as a core regulatory representative on cross-functional 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 follow-up 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:
• Bachelor's 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 clinical-stage regulatory activities
• Demonstrated working knowledge of FDA, EMA, and other global health authority regulations applicable to clinical development
• Hands-on experience preparing and/or managing INDs, CTAs, and clinical regulatory submissions across multiple regions
• Experience supporting regulatory strategy for early- and mid-stage 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 drug-diagnostic development activities, is a plus
• Familiarity with eCTD structure and regulatory document authoring requirements
• Ability to work effectively in a fast-paced, matrixed environment while managing multiple priorities
• Strong written and verbal communication skills, with the ability to clearly convey regulatory considerations to cross-functional 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 $170,000 - $210,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.
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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 Allogene's pipeline. Reporting to the Senior Director, Regulatory Affairs, this position will serve as a core regulatory representative on cross-functional 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 follow-up 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:
• Bachelor's 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 clinical-stage regulatory activities
• Demonstrated working knowledge of FDA, EMA, and other global health authority regulations applicable to clinical development
• Hands-on experience preparing and/or managing INDs, CTAs, and clinical regulatory submissions across multiple regions
• Experience supporting regulatory strategy for early- and mid-stage 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 drug-diagnostic development activities, is a plus
• Familiarity with eCTD structure and regulatory document authoring requirements
• Ability to work effectively in a fast-paced, matrixed environment while managing multiple priorities
• Strong written and verbal communication skills, with the ability to clearly convey regulatory considerations to cross-functional 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 $170,000 - $210,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.
Apply tot his job
Apply To this Job