Director of Regulatory Affairs

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