Manager Research Regulatory Affairs

About the role

As the Manager of Regulatory Affairs, you will oversee all aspects of the regulatory operations for Sarah Cannon Site Clinical Operations and manage the Regulatory Department. You will develop and implement short and long-term strategies for regulatory compliance for site Clinical Operations, ensuring adherence to FDA regulations and overseeing regulatory audits. You will collaborate closely with department directors, primary investigators, industry sponsors, and external entities.

Responsibilities

• Manage, direct, plan, and schedule activities and programs for the Regulatory Department.
• Establish and enforce procedures to ensure all trial teams and sites comply with applicable laws, regulations, SOPs, and guidelines.
• Develop and implement regulatory policies and procedures for sites and the site Clinical Operations team, including managing compliance for industry sponsors and sites.
• Oversee regulatory affairs for multiple clinical trials according to FDA and Good Clinical Practice (GCP) guidelines.
• Manage relationships between industry partners and the FDA regarding regulatory compliance and audits.
• Resolve key regulatory issues with pharmaceutical industry partners and government agencies.
• Develop and implement an approved archiving system for study-specific regulatory documentation and correspondence.
• Apprise management of important regulatory issues and seek guidance when necessary.
• Attend network meetings, conference calls, and monthly staff meetings as appropriate.
• Visit strategic sites to provide training and mentoring as needed.
• Provide proactive and creative recommendations to meet goals and address identified deviations.
• Oversee objective setting, performance management, education, and training of regulatory staff, including developing Lead Regulatory Affairs Specialists.
• Implement, manage, and refine departmental processes, coordinating with clinical personnel on research conduct and client service issues.
• Initiate improvements, tools, and forms to enhance efficiency and quality of work on assigned projects.

Requirements

• Bachelor’s Degree.
• Knowledge of scientific and clinical research terminology.
• Knowledge of FDA and GCP guidelines.
• Knowledge of organizational policies, procedures, and systems.
• At least three years of experience in regulatory affairs.
• At least one year of experience in a supervisory role.

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians enrolling patients into clinical trials at over 200 locations in 20+ states across the U.S.

Benefits

We offer a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our offerings are designed to meet the diverse needs of our colleagues and ensure they are the healthiest versions of themselves. Benefits are provided through our parent company, McKesson.

Pay

We offer a competitive compensation package determined by performance, experience, skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation such as an annual bonus or long-term incentive opportunities may be offered.