Director of Regulatory Affairs
Job Summary
Leading regulatory strategy and submission execution for oncology development programs, the full-time Director of Regulatory Affairs will manage regulatory submissions, develop global regulatory strategies, and represent Regulatory Affairs on cross-functional teams in a fully remote environment.
Key Responsibilities
- Lead hands-on regulatory submission activities and manage communication with CROs to ensure timely submissions
- Develop and execute global regulatory strategies for early-phase through late-stage clinical development programs
- Serve as the Regulatory Affairs representative on cross-functional teams and lead interactions with regulatory agencies
Required Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline; advanced degree preferred
- Approximately 10-12 years of regulatory affairs experience within biotechnology or pharmaceutical drug development, with a focus on oncology
- Demonstrated experience leading regulatory submissions and strategy for oncology development programs
- Extensive knowledge of FDA, EMA, ICH, and other global regulatory requirements
- Strong understanding of oncology drug development from First-in-Human through commercialization
Complete Job Description
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