Remote Regulatory Affairs Manager – Oncology Trials

JSC SCRI Holdings LLC; Tennessee; Hybrid; USD 95,000 - 135,000; Full time

Benefits offered by this job

Total Rewards package

Competitive compensation

Benefits overview via McKesson

Job summary

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Regulatory Affairs Manager to oversee regulatory operations for Clinical Operations. This remote role requires ensuring FDA and GCP compliance across sites and managing audits with sponsors and regulators.

The position partners with department directors and investigators to implement short- and long-term regulatory strategies, supporting an expanding oncology trial portfolio.

Qualifications

• Bachelor's Degree required; 1+ year in regulatory roles preferred.
• Knowledge of FDA and GCP guidelines and clinical terminology.
• Experience interacting with sponsors, regulators, and sites.
• Strong MS Office skills and ability to manage deadlines.

Responsibilities

• Oversees regulatory operations for site Clinical Operations.
• Develops and implements short- and long-term regulatory strategies.
• Ensures FDA regulatory compliance and oversees regulatory audits.
• Collaborates with department directors and primary investigators.
• Liaises with sponsors and external regulators on behalf of the organization.

Skills

MS Office

FDA & GCP knowledge

Regulatory affairs

Clinical research terminology

Education

Bachelor's Degree

Job description

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Regulatory Affairs Manager to oversee regulatory operations for Clinical Operations. This remote role requires ensuring FDA and GCP compliance across sites and managing audits with sponsors and regulators.

The position partners with department directors and investigators to implement short- and long-term regulatory strategies, supporting an expanding oncology trial portfolio.