Director, Regulatory Affairs Operations

Company: Kura Oncology, Inc.

Job Description

Responsible for the management and oversight of regulatory submissions, systems, and procedures. This includes planning, coordinating, and ensuring the quality and compliance of regulatory submissions, interfacing with external publishing vendors, and managing regulatory information systems.

Key Responsibilities

• Lead the development of internal procedures
• Mentor staff
• Manage vendor relationships

Requirements

• BA/BS degree
• Minimum 10 years of regulatory operations experience in biotech/pharma
• Advanced knowledge of submission requirements
• Extensive eCTD filing experience