Regulatory Research Operations Lead

McKesson; Tennessee; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Sarah Cannon Research Institute (SCRI) is seeking a Senior Manager for Research Regulatory Affairs to lead regulatory start-up and ongoing maintenance of cancer trial programs. You will work closely with site teams, budgets, contracts, and finance to optimize regulatory processes and performance.

The role requires strong leadership, communication with internal and external partners, and a track record in regulatory affairs within clinical research.

Qualifications

• Bachelor’s degree required; Master’s preferred.
• Minimum three years of research experience on site or in industry.
• Minimum three years of management with direct reports.

Responsibilities

• Oversee regulatory start-up and maintenance of trials.
• Collaborate with sites, study activation, budget, and contracts teams.
• Develop and implement regulatory policies for sites and Clinical Operations.
• Manage regulatory affairs across multiple trials per FDA and GCP guidelines.
• Lead and develop the regulatory team, set direction, and ensure productivity.
• Provide KPI metrics and reporting to department managers.
• Interact with sponsors/CROs, IRBs, and site teams.

Skills

Regulatory leadership

Budget management

Stakeholder management

Education

Bachelor's degree

Master's degree (preferred)

ACRP/CCRP certification (preferred)

Job description

Sarah Cannon Research Institute (SCRI) is seeking a Senior Manager for Research Regulatory Affairs to lead regulatory start-up and ongoing maintenance of cancer trial programs. You will work closely with site teams, budgets, contracts, and finance to optimize regulatory processes and performance.

The role requires strong leadership, communication with internal and external partners, and a track record in regulatory affairs within clinical research.