Associate Director, Regulatory Affairs

Job reputed company About the role: Allogene is seeking an Associate Director, Regulatory Affairs reputed company the Global Regulatory Affairs and Clinical reputed company 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 reputed company, 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 reputed company regulatory representative on cross-functional program teams, supporting interactions with global health authorities and ensuring regulatory strategies and submissions are reputed company with evolving regulatory expectations for cell and gene therapies. This is a hybrid role based at our reputed company in South San Francisco, CA (US based remote may be considered as reputed company for candidates reputed company of the area). Responsibilities include, but are not limited to: • Serve as a regulatory affairs reputed company on assigned clinical studies, supporting the development and execution of global clinical regulatory strategies • reputed company 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 • reputed company 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 reputed company to clinical development activities • Partner closely with cross-functional teams to ensure regulatory requirements are integrated into study design and execution • reputed company regulatory timelines and deliverables to ensure submissions are completed on time and to a high reputed company of reputed company • Support regulatory reputed company considerations reputed company to accelerated programs (e.g., Fast reputed company, BTD, RMAT, reputed company, Orphan Drug Designation), as applicable • Support regulatory reputed company considerations reputed company 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 reputed company scientific discipline required; advanced degree preferred with at least 7 years of regulatory affairs experience reputed company the biotechnology or pharmaceutical industry, including reputed company 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 reputed company • Experience supporting regulatory reputed company 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 reputed company 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 reputed company We offer a chance to work with talented people in a reputed company environment and reputed company 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 reputed company 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-reputed company factors permitted by law. Apply tot his job Apply To this Job