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Regulatory Affairs Intern, CMC (Summer 2023)

Internships | Hybrid in South San Francisco, CA | Full Time, Temporary, and Internship | From $25.00 to $28.00 per hour

Job Description

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About Allogene Therapeutics, Inc:

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:

Gain hands-on experience through an extensive overview of the biopharmaceutical industry and experience cutting-edge oncology drug development. Work on projects that improve your collaboration, problem solving, and critical thinking skills. Network and gain cross-functional exposure to CMC and Clinical Regulatory Affairs, Regulatory Operations, and Technical Operations teams within Allogene. Work with knowledgeable mentors and develop basic regulatory skills to build a strong career foundation.

Responsibilities include, but are not limited to:

  • Contribute to the success of CMC Regulatory objectives by creating regulatory templates per the electronic submission standards
  • Assist with preparation of CMC regulatory submission documents including amendments, annual reports, notifications to investigational new drug applications and clinical trial applications for cell therapy and biologics products
  • Conduct regulatory precedence-based research by thoroughly reviewing approval summaries of licensed cell therapy products and assessing prior approvals for key questions that may exist within the Allogene CMC teams
  • Other duties as assigned

Position Requirements & Experience:

  • Must have a minimum GPA of 3.0
  • Currently enrolled full-time and have completed at least 2 years in an undergraduate program or enrolled in a graduate program (preferred) at an accredited US based university. Candidate must be pursuing a degree (i.e., BS, MS, PhD, or PharmD) in Regulatory Affairs, Biology, Chemistry, Pharmacy, or a related field
  • Basic understanding of drug development and associated regulatory requirements/guidelines
  • Advanced computer software skills with Word, Excel, and PowerPoint
  • 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.
  • 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. The expected rate range for this role is $25.00 - $28.00 per hour. 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.

Please be aware that the FBI recently issued a warning about an increased number of fake job postings for remote work employment that target applicants' personally identifiable information. All approved Allogene Therapeutics positions are accessible via the Allogene Careers page at www.allogene.com/careers


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