Manager Research Regulatory Affairs

Oversee all regulatory operations for Sarah Cannon Site Clinical Operations and manage the Regulatory Department. Develop and implement short and long-term strategies for regulatory compliance while ensuring adherence to FDA guidelines and overseeing regulatory audits. Direct, plan, and schedule departmental activities; establish and enforce procedures to assure full compliance with laws, regulations, SOPs, and guidelines. Manage regulatory affairs across multiple clinical trials according to FDA and GCP standards, resolving key issues with industry partners and government agencies. Develop an approved archiving system for study documentation and provide training and mentoring to strategic sites. Apprise management of critical regulatory issues and initiate improvements to enhance work efficiency and quality.