Senior Manager, Regulatory Writing

Reporting to the Director, Regulatory Writing, CARGO Therapeutics is seeking a highly motivated Senior Manager, Regulatory Writing within Regulatory Affairs. This individual will be responsible for the development of US and global regulatory clinical and regulatory submission documents for CARGO's cell therapy pipeline. The ideal candidate must have a deep knowledge of regulatory submission requirements in major regions (eg: US, EU). The successful candidate will work closely with colleagues in Regulatory, Research, Translational Medicine, Clinical Development, Safety, and Biostatistics, as both the document lead and an individual contributor for the development of complex documents supporting IND, BLA, and other regulatory submissions. This individual will also support the development of processes and promote writing best practices to ensure document preparation is high quality and on time. This is an individual contributor role.

The role can be Remote or located at Headquarters in San Carlos, CA.

WHAT YOU'LL DO AT CARGO THERAPEUTICS

• Lead and individually contribute to regulatory writing activities, manage/perform QC review, and coordinate publishing activities to achieve on-time submissions

• Work effectively with cross-functional teams and external partners to ensure the production of high-quality, scientifically accurate documents under accelerated timelines, and ensure consistent messaging between related

• Demonstrate technical/scientific ability to critically analyze, synthesize, and present complex information in a clear, concise, and well‑constructed document

• Prioritize tasks, multitask on projects, and ensure the completion of high-quality documents according to accelerated timelines and shifting priorities/demands

• Exhibit strong project management and leadership skills

• Assist in developing and maintaining regulatory writing processes and templates and ensure consistency with CARGO standards and tools (SOPs, Work Instructions, templates, style guide, document management system, etc.); ensure strategic regulatory documents adhere to regulatory guidelines

• Train and support cross-functional team members in document management system use

• Stay abreast of FDA, EMA and ICH guidelines and regulatory requirements

• May manage contractors or external writers as needed

THE RIGHT STUFF: Required Experience & Qualifications

• Minimum BA/BS degree; Master's/PhD/PharmD in life sciences preferred

• At least 4 years of relevant industry experience in a pharmaceutical or biotech company in a clinical regulatory writing position is required

• Direct experience authoring clinical and regulatory documents such as: clinical protocols, clinical study reports, investigator's brochures, briefing documents, pediatric study plans, special applications (orphan drug designations, breakthrough therapy, fast track, etc.), and clinical components of INDs and BLAs/MAAs

• Proven track record in leading IND and BLA/NDA/MAA key messaging and preparation of storyboards is preferred

• Advanced knowledge of FDA, EMA and ICH guidelines and regulatory requirements

• Oncology experience is required; Biologics, specifically cell therapy, experience is helpful

• Experience using Veeva Vault RIM preferred

PAY RANGE

The combined pay range for this role is $148,000 - $204,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.

ABOUT CARGO THERAPEUTICS

CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO's programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic "cargo" designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO's founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-tx.com/.

Join us to help make a difference!

EEO & EMPLOYMENT ELIGIBILITY

CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.

CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.