Regulatory Affairs Specialist II

About the role

Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.

A Regulatory Affairs Specialist II position is available in the Diamond Research Laboratory. You will assist and support internal and external PIs for timely and accurate submissions related to clinical protocols under their jurisdiction.

Responsibilities

• Prepare, review, and compile Investigational New Drug Application (IND) Annual Reports.
• Review protocol amendments and documentation for informational amendments.
• Review safety documentation.
• Interact with internal personnel, including investigators and their staff (clinical research nurse and coordinator, biostatistician, and scientific leads), as well as Manufacturing, Quality Control, and Quality Assurance staff.
• Assist with regulatory maintenance, amendments/approvals (IRB, IBC, and IACUC), and training documentation to ensure regulatory compliance.
• Lead in the design and development of clinical protocols, consent forms, SOPs, and other documents required by the project.
• Ensure compliance with protocol, regulatory, and overall clinical and quality objectives.
• Compose, edit, or review laboratory SOPs, and review/revise manufacturing and quality testing SOPs.
• Write pre-clinical and clinical documents, handle submissions for iRIS, and respond to regulatory authorities.
• Communicate critical information related to project timelines and core project teams.
• Act independently to determine methods and procedures for new projects.

Requirements

• Bachelor’s degree in a scientific discipline or equivalent; Master’s degree preferred.
• 2–5 years of regulatory affairs experience with a Bachelor’s or 0–2 years with a Master’s.
• Preferred experience within regulatory affairs, clinical trials management, or a relevant scientific field.
• RAPS, SOCRA, or ACRP Certification is preferred but not required.

Pay

City of Hope employees pay is based on work experience, qualifications, and work location.

Benefits

To learn more about our comprehensive benefits, please click here.