We’re seeking a skilled Clinical Trial FDA Regulatory Writer to join our team. In this critical role, you will be responsible for preparing and managing regulatory documents and submissions to the FDA, ensuring all clinical trials adhere to regulatory requirements.

QUALIFICATIONS:

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• 3-5+ years of direct FDA regulatory experience in the biotechnology or pharmaceutical industry, specifically with clinical trials.
• Strong experience in working with the FDA on INDs and amendents.
• Proven experience preparing and managing INDs and amendments.
• Strong understanding of 21 CFR regulations (Parts 50, 54, 56, 312) and ICH GCP.
• Excellent written and verbal communication, meticulous attention to detail, and strong organizational skills.
• Ability to thrive in a fast-paced, collaborative biotech environment.
• Hybrid role but MUST be based out of Los Angeles, CA.

• Lead the preparation, writing, and review of key FDA submissions, including Investigational New Drug (IND) applications and all amendments, annual reports, and safety reports specifically for biologics.
• Provide expert guidance on FDA regulations (21 CFR) and Good Clinical Practice (GCP) guidelines.
• Manage regulatory compliance for all clinical trial documentation and activities.
• Facilitate and support formal interactions and communications with the FDA.