Director of Regulatory Operations

Job Summary

Seeking a remote, full-time Associate Director of Regulatory Operations, this role will manage the operational backbone of global regulatory filings, overseeing submission planning, publishing, and delivery to FDA and international health authorities while ensuring data integrity in the Regulatory Information Management System (RIMS).

Key responsibilities:

• Lead end-to-end management of regulatory submissions, including INDs and CTAs, ensuring timely and compliant dispatch
• Oversee the administration of the RIMS platform, maintaining data integrity and leading system enhancements
• Act as the primary contact for CROs, managing deliverables, timelines, and quality oversight for submissions

Required qualifications:

• Bachelor's degree in a life science, information science, or related field
• 8+ years of regulatory operations experience in biotech, pharmaceutical, or CRO environments
• Hands-on knowledge of eCTD structure and lifecycle management, with experience in US and at least one ex-US region
• Direct experience preparing and submitting INDs and/or CTAs, including collaboration with CROs
• Demonstrated ownership of a RIMS platform, ensuring data integrity and compliance with regulatory standards