[Hiring] Manager of Research Regulatory Affairs @McKesson

Role Description

As the Manager of Research Regulatory Affairs, you will oversee all aspects of the regulatory operations for Sarah Cannon Research Institute (SCRI) and manage the Regulatory Department. Your responsibilities will include:

• Developing and implementing short- and long-term strategies for regulatory compliance for the site Clinical Operations.
• Ensuring SCRI adheres to and maintains Food and Drug Administration (FDA) regulatory compliance.
• Overseeing any regulatory audits.
• Managing, directing, planning, and scheduling activities and programs for the regulatory department.
• Establishing and enforcing procedures to ensure compliance with applicable laws, regulations, standard operating procedures (SOPs), and guidelines.
• Developing and implementing regulatory policies and procedures for the sites and the site Clinical Operations team.
• Managing regulatory affairs for multiple clinical trials according to FDA and Good Clinical Practice (GCP) guidelines.
• Managing relationships between industry partners and the FDA regarding regulatory compliance.
• Resolving key regulatory issues with Pharmaceutical Industry Partners and Government Agencies.
• Developing and implementing an approved archiving system for study-specific regulatory documentation and correspondence.
• Apprising management of important regulatory issues and obtaining guidance when necessary.
• Attending network meetings, conference calls, and monthly staff meetings as appropriate.
• Visiting strategic sites and providing training and mentoring as needed.
• Providing proactive and creative recommendations on how to meet goals and handle identified deviations.
• Setting objectives, managing performance, and providing education and training for the regulatory staff.
• Implementing, managing, and refining departmental processes, and coordinating with clinical personnel around research and client service issues.
• Initiating improvements, tools, and forms to enhance efficiency and quality of work on assigned projects.

Qualifications

• A 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.

Benefits

• Comprehensive benefits to support physical, mental, and financial well-being.
• Competitive compensation package determined by performance, experience, skills, equity, and geographical markets.
• Potential for annual bonuses or long-term incentive opportunities.

Company Description

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Key points include:

• Focused on advancing therapies for patients over the last three decades.
• Leader in drug development with over 850 first-in-human clinical trials conducted.
• Contributed to pivotal research leading to the majority of new cancer therapies approved by the FDA in the past decade.
• Research network includes more than 1,300 physicians enrolling patients into clinical trials at over 200 locations across 20+ states in the U.S.