Regulatory Affairs Specialist I

About the Role

City of Hope’s Beckman Research Institute is advancing research that aims to improve outcomes for cancer, diabetes, and other serious diseases. In this position, you will join the Office of IND Development and Regulatory Affairs within the Center for Bioinnovation and Manufacturing to help manage regulatory work for investigator-initiated Investigational New Drug (IND) programs.

The role focuses on preparing, checking, assembling, submitting, and tracking IND-related filings. Working under supervision, you will help maintain the regulatory lifecycle for assigned INDs and review regulatory records to help ensure alignment with institutional standards, FDA rules, and ICH/GCP expectations. You will also coordinate with investigators, study teams, and internal partners so documents are complete, accurate, and submitted on schedule.

Key Responsibilities

• Draft, review, compile, and assist with the submission of regulatory materials for assigned research INDs, including initial submissions, annual reports, protocol changes, information updates, and safety reports.
• Support the preparation of single-patient IND requests for non-emergency use.
• Examine investigator regulatory files and site records such as Form FDA 1572s, IRB approvals, and related documentation for accuracy, completeness, and regulatory alignment.
• Help maintain adherence to applicable regulatory requirements, institutional and departmental procedures, FDA regulations and guidance, and GCP standards.
• Coordinate with researchers and cross-functional stakeholders to keep regulatory documentation current and submitted within required timelines.
• Continue building professional expertise through seminars, workshops, professional memberships, and other learning opportunities.

Qualifications

• A bachelor’s degree in a scientific field, regulatory affairs, or a related discipline with 3 to 5 years of relevant experience, or a master’s/PhD in a related scientific or regulatory field with 0 to 2 years of experience.
• Prior experience in regulatory affairs or another FDA-regulated environment is required.
• Regulatory Affairs Certification (RAC) or a similar credential is preferred.
• Strong written, editing, and spoken communication abilities.
• Excellent organization, time management, and the ability to handle multiple deadlines and competing priorities in a fast-moving setting.
• Strong analytical judgment, critical thinking, proofreading, and document review capabilities.
• Working understanding of FDA requirements and guidance related to IND submissions.

Additional Information

Compensation is determined by work experience, qualifications, and job location. City of Hope is an equal opportunity employer. Comprehensive benefits information is available through the employer’s benefits program.