Regulatory Affairs Lead

I'm partnered with a mid-sized global CRO to identify a Regulatory Affairs Lead to support US FDA submissions across multiple therapeutic areas. This position focuses on hands-on regulatory execution and submission delivery.Key ResponsibilitiesPrepare, compile, and submit regulatory filings (INDs, pre-INDs, NDAs, amendments, etc.) in compliance with FDA requirements.Ensure submission packages and forms are accurate, complete, and formatted to eCTD standards.Collaborate cross-functionally to coordinate data and documentation for timely, high-quality submissions.Apply strong knowledge of US regulatory pathways and submission processes from initiation through approval.Stay current with evolving FDA and ICH regulations to ensure compliance.Requirements5-8 years of regulatory affairs experience.3+ years of Contract Research Organization (CRO) experience.Demonstrated experience preparing and submitting INDs and NDAs.Strong understanding of FDA, ICH, and GCP frameworks.Excellent attention to detail, organization, and communication skills.Bachelor’s degree in life sciences or related field (advanced degree preferred).The ideal candidate will have had exposure to oncology, rare disease, or biologics development programs and experience from early-phase to registration.This is a 100% remote US-based position.