Senior Director, Regulatory & Scientific Affairs

Job description

Job Summary: The Senior Director, Regulatory and Scientific Affairs, is responsible for developing and executing global regulatory strategies to support the advancement of clinical development programs from early development through registration and lifecycle management. This role will advise sponsors on regulatory pathways and ensure that regulatory strategies align with their clinical, scientific, and corporate goals. The Senior Director, RSA will provide expert guidance on regulatory requirements, risk mitigation, and health authority engagement, ensuring regulatory strategies are scientifically sound, operationally feasible, and aligned with global regulatory expectations. The individual serves as a strategic partner to sponsors and internal cross-functional teams. This role also contributes to business development activities, including proposals, capabilities meetings, and pipeline development, and plays a critical role in establishing CTI as a strategic regulatory partner to sponsors. What You’ll Do: - Serve as a regulatory strategy lead and scientific advisor for sponsor programs across multiple therapeutic areas. - Develop and advise on global regulatory strategies supporti...