Manager of Regulatory Affairs - Remote US

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

It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting‑edge research, SCRI is redefining cancer care around the world.

Our Regulatory Affairs Manager oversees all aspects of the regulatory operations for Sarah Cannon site Clinical Operations and manages the regulatory department. This position is responsible for developing and implementing short‑and‑long‑term strategies for the regulatory compliance for the site Clinical Operations. You will ensure Sarah Cannon adheres to and maintains FDA regulatory compliance as well as oversees any regulatory audit. This position will work closely with the department directors and/or primary investigators, industry sponsors and other outsides entities. This is a remote position based in the US; relocation assistance and visa sponsorship are not available.

Duties

• Manages, directs, plans and schedules activities and programs for the regulatory department
• Establishes and enforces procedures that assure all trial teams and sites are fully compliant with all applicable laws, regulations, SOPs, and other applicable guidelines
• Develops and implements regulatory policies and procedures for the sites and the site Clinical Operations team, including managing and planning regulatory affairs compliance for industry sponsors and/or sites
• Manages the regulatory affairs between the organization for multiple clinical trials according to FDA and GCP guidelines; for individual sites, studies, sponsors and/or other networks
• Manages the relationships between industry partners and the FDA regarding regulatory compliance for the organization and managing regulatory audits of studies by sponsor/industry and governmental auditors

Other duties as assigned.

Qualifications

• Bachelor's Degree
• 1+ year work experience with 5+ years' preferred in clinical research corporation and regulatory team - education may be substituted for partial experience
• Knowledge of scientific and clinical research terminology
• Knowledge of FDA and GCP guidelines
• Knowledge of organizational policies, procedures, and systems
• Advanced skills with MS Office products including Excel, Word, Outlook
• Experience meeting strict deadlines and supervising team members

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 who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.

Please click here to learn more about our research offerings.

Benefits and Compensation

We care about the well‑being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well‑being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and 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.

Equal Opportunity Employer

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.