Senior Director Regulatory Affairs

Key Responsibilities: Develop and execute regulatory strategies supporting clinical development and future product approvals. Lead and support preparation and submission of regulatory filings, including INDs, NDAs, and international submissions. Provide regulatory guidance to cross-functional teams throughout the product development lifecycle. Ensure compliance with FDA and global regulatory requirements while monitoring evolving regulations and industry guidance. Identify regulatory risks and develop mitigation strategies. Support regulatory aspects of quality systems, including GCP and GLP compliance.

Qualifications: Advanced degree with 10+ years of regulatory affairs experience, or Bachelor's degree with 12+ years of relevant experience. Strong knowledge of FDA and global regulatory frameworks (including Europe and Asia-Pacific markets).Proven experience developing regulatory strategy and managing clinical regulatory submissions. Excellent communication, collaboration, and project management skills. Ability to operate as a senior individual contributor in a fast-paced biotech or pharmaceutical environment. Oncology regulatory experience is required.