Associate Director, Regulatory Writing - Allogene Therapeutics

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:

Allogene Therapeutics is seeking a highly motivated Associate Director, Regulatory Writing in the Regulatory Affairs group. The ideal candidate is an individual who is interested in working in a fast-paced, dynamic, and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges.

We encourage applicants who believe they have the skills and drive to succeed at Allogene to apply for this role.

Responsibilities include, but are not limited to:

• Regulatory Document Development:
  • Research, author, and edit regulatory documents in compliance with Good Clinical Practice (GCP), applicable regulatory requirements, and company SOPs, including but not limited to clinical study reports (CSRs), protocols, Investigator Brochures (IBs), and regulatory submissions (e.g., BLAs, MAAs, INDs, CTAs).
  • Ensure all documents convey clear and consistent messaging that aligns with project goals.
• Leadership and Team Management:
  • Leading cross-function teams preparation of regulatory documents.
  • Provide strategic oversight for multiple programs, coordinating writing resources and contributing to project messaging.
• Cross-Functional Collaboration:
  • Collaborate with various internal teams (e.g., Clinical Development, Regulatory Affairs, Pharmacovigilance, Biostatistics, Translational, Quality, CMC) to ensure timely delivery of high-quality, scientifically justified documents.
  • Provide editorial support and strategic guidance for scientific publications, abstracts, posters, and presentations.
• Process Improvement:
  • Proactively identify opportunities to enhance regulatory writing processes, including the development and standardization of templates.
  • Serve as a subject matter expert at conferences and professional meetings, showcasing the expertise of the writing team.
• Mentorship and Coaching:
  • Contributing to the broader organizational goals of continuous improvement.
  • Assist with day-to-day operational activities and special projects as assigned by management.

Position Requirements & Experience:

• Advanced degree (e.g., PhD, PharmD) with a minimum of 6 years of regulatory/medical writing experience in the pharmaceutical industry, or a Bachelor’s degree in a scientific discipline with 10+ years of relevant experience in pharmaceuticals, biotechnology, or CROs.
• Proven experience in preparing regulatory and clinical documents for submission to U.S. FDA (NDA, BLA) and/or EMA (MAA).
• Ability to effectively work in a fast-paced, biotech environment, while dealing with ambiguity
• 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 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 to $210,000. 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.

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