Oncology Research Regulatory Affairs Manager

Mckesson Corporation; North Carolina; Hybrid; USD 125,000 - 180,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Sarah Cannon Research Institute (SCRI) is a leading oncology research organization conducting community-based clinical trials across the U.S. SCRI is a subsidiary of McKesson, focused on advancing cancer therapies and improving patient outcomes.

The Manager of Research Regulatory Affairs will oversee all regulatory operations for SCRI, manage the Regulatory Department, and develop short- and long-term regulatory strategies for Clinical Operations.

Qualifications

• 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.

Responsibilities

• Oversee all aspects of regulatory operations for SCRI and manage the Regulatory Department.
• Develop and implement short- and long-term strategies for regulatory compliance for Clinical Operations.
• Ensure FDA regulatory compliance and oversee regulatory audits.
• Coordinate with department directors, primary investigators, sponsors, and external entities.
• Manage, plan and schedule activities for the regulatory department.
• Establish and enforce procedures to ensure trial teams/sites comply with laws, SOPs and guidelines.
• Develop and implement regulatory policies for sites and Clinical Operations.
• Manage regulatory affairs across multiple clinical trials per FDA and GCP guidelines.
• Maintain relationships with FDA and industry partners regarding regulatory compliance.
• Resolve key regulatory issues with industry partners and government agencies.
• Develop an archiving system for study regulatory documentation.
• Advise management on regulatory issues and provide guidance as needed.
• Attend network meetings, training and mentor staff as needed.
• Drive improvements, tools and forms to enhance efficiency and quality.

Education

Bachelor's Degree

Job description

Sarah Cannon Research Institute (SCRI) is a leading oncology research organization conducting community-based clinical trials across the U.S. SCRI is a subsidiary of McKesson, focused on advancing cancer therapies and improving patient outcomes.

The Manager of Research Regulatory Affairs will oversee all regulatory operations for SCRI, manage the Regulatory Department, and develop short- and long-term regulatory strategies for Clinical Operations.