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Senior Associate, Regulatory Affairs
4 months ago
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. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn. About the role: The Senior Associate will support all aspects of regulatory affairs related to the development of novel CAR T therapies including quality, preclinical and clinical areas of drug development. Responsibilities include: Assist in the authoring, submission, and maintenance of global regulatory submissions related to clinical, CMC and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigators Brochure. Assist in coordination and preparation for Agency meetings and associated briefing documents. Collaborates with subject matter experts to provide written responses to queries. Leads and tracks queries and commitments with regulatory agencies and helps maintain commitment tracker and Health Authority questions database. Provide representation for study-level regulatory activities at study management teams. Author Cover Letters, Form FDA 1571, and other administrative documents to support routine submissions to FDA. Assist interactions with publishing vendor to support timely delivery of final documents for electronic publishing. Conduct regulatory intelligence projects as assigned to support clinical strategy decisions. Assist in authoring of Standard Operating Procedures. Requirements: Bachelors degree preferred in the sciences, or health related field. Interest in building a career in Regulatory Affairs. Strong knowledge of eCTD elements and structure including CMC. 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 to drive for 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. 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 $110,000 to $140,000. 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. #LI-EL1
