Director, Regulatory Affairs Operations

Kura Oncology, Inc.

Job Description

Responsible for the management and oversight of regulatory submissions, systems, and procedures. This includes submission content and timeline planning, dossier compilation, QC review, and acting as a submission manager. The role involves ensuring document management compliance, managing regulatory records, and overseeing electronic document and regulatory information management systems.

Requirements

• BA/BS degree
• 8-10+ years of regulatory operations experience in a biotech or pharmaceutical environment
• Advanced knowledge of submission requirements and eCTD filing