Kura Oncology, Inc. logo

Associate Director, Regulatory Affairs Operations (Boston)

Kura Oncology, Inc.
Full-time
Remote friendly (Boston, MA)
Worldwide
Other
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Associate Director, Regulatory Affairs Operations (Boston)

Company Name

Kura Oncology, Inc.

Job Overview

The Associate Director, Regulatory Affairs Operations manages and oversees regulatory submissions, systems, and procedures.

Responsibilities

  • Interfacing with external vendors for submission preparation
  • Supporting eCTD activities
  • Tracking correspondence
  • Implementing regulatory systems
  • Leading the development of procedures
  • Managing vendors
  • Providing strategic insights on regulatory technologies

Requirements

  • BA/BS
  • 8+ years of regulatory operations experience in biotech/pharma
  • Advanced knowledge of submission standards
  • Extensive eCTD filing experience
  • Strong attention to detail
  • Excellent communication skills