Associate Director, Regulatory Operations (Boston)

Company Name

Kura Oncology, Inc.

Job Overview

The Associate Director, Regulatory Operations is responsible for the operational aspects of regulatory submissions and supports regulatory systems. This role involves managing external publishing vendors for global health authority submissions, ensuring compliance, quality, and timeliness.

Key Duties

• Compilation, archiving, and tracking of submissions and correspondence.
• Managing and implementing regulatory systems.

Requirements

• Knowledge of US/international regulatory requirements.
• Familiarity with eCTD standards.
• Veeva RIM Administrator experience.
• Ideally 8+ years in life sciences.
• 5+ years in regulatory operations.