Regulatory Affairs Specialist I

City of Hope

2d•Onsite

About The Position

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. We are looking for a Regulatory Affairs Specialist under the Office of IND Development and Regulatory Affairs, Center for Bioinnovation and Manufacturing. You will support the preparation, review, compilation, submission, and maintenance of investigator-initiated Investigational New Drug (IND) applications and related regulatory filings. Under supervision, you will assist with regulatory submission activities, lifecycle management of assigned INDs, and review of investigator regulatory files to support compliance with applicable institutional requirements, FDA regulations and guidance, and ICH and Good Clinical Practice (GCP) guidelines. You will also collaborate with investigators, study teams, internal departments, and other stakeholders to ensure regulatory documents are accurate, complete, and submitted in a timely manner.

Requirements

Bachelor's Degree in scientific discipline, regulatory affairs, or a related field with a minimum of 3-5 years of experience or a Masters/PhD in scientific discipline, regulatory affairs, or a related field with a minimum of 0-2 years of experience.
Experience within regulatory affairs or in a related FDA-regulated industry is required
Excellent written, editorial and verbal communication skills.
Strong organizational skills and demonstrated ability to manage deadlines, competing priorities, and regulatory deliverables in a fast-paced environment.
Strong analytical, critical thinking, proofreading, and document review skills.
Working knowledge of FDA regulatory requirements and guidance related to INDs.

Nice To Haves

Regulatory Affairs Certification (RAC) or other relevant regulatory certification is preferred

Responsibilities

Prepare, review, compile, and support submission of regulatory documents for assigned research IND applications, including initial INDs, annual reports, protocol amendments, information amendments, and safety reports.
Support preparation of non-emergency use single-patient IND submissions.
Review investigator regulatory files and site documentation, including Form FDA 1572s, IRB approvals, and related documents, for accuracy, completeness, and compliance.
Assist with maintaining compliance with applicable regulatory requirements, institutional and departmental policies, FDA regulations and guidance, and GCP guidelines.
Maintain professional growth and development by participating in seminars, workshops, professional affiliations, and other learning opportunities to remain current with regulatory affairs practices.
Ensure compliance with applicable regulatory, departmental, institutional policies and FDA guidance rulings, as well as ensuring compliance with Good Clinical Practice (GCP) guidelines for research programs.