Director, Regulatory Affairs Operations (Boston)
Kura Oncology, Inc.
Full-time
Remote friendly (Boston, MA)
Worldwide
Operations
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Director, Regulatory Affairs Operations (Boston)
Company Name
Kura Oncology, Inc.
Job Overview
The Director, Regulatory Affairs Operations manages and oversees regulatory submissions, systems, and procedures.
Responsibilities
- Interfacing with external vendors for submission preparation
- Providing operational oversight for eCTD activities
- Managing the tracking, archiving, and documentation of submissions and health authority correspondence
- Managing regulatory records
- Overseeing electronic document and information management systems (e.g., Veeva RIM)
- Developing procedures
- Managing staff and vendors
Requirements
- BA/BS degree
- Minimum 10 years of regulatory operations experience in biotech/pharma
- Advanced knowledge of submission requirements and publishing standards