Regulatory Affairs Specialist

Job not on LinkedIn

🕒 2 days ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

City of Hope

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

🔬 Science

🤝 Non-profit

💰 $5.4M Grant - City of Hope on 2024-05

Biotechnology • Science • Non-profit

City of Hope is a nonprofit, NCI-designated comprehensive cancer center and research hospital near Los Angeles that provides patient care, conducts translational biomedical research, and offers education and clinical trials across a national network. It focuses on cancer, diabetes, and other life‑threatening diseases, combining clinical services, laboratory science, training and community outreach to develop new treatments and support patients and families.

📋 Description

• 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.

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

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development