Manager Research Regulatory Affairs

McKesson’s Corporate; Tennessee; On-site; USD 120,000 - 170,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI) is seeking a Manager of Research Regulatory Affairs to lead the Regulatory Department and ensure FDA compliance across Clinical Operations. You will develop regulatory strategy, oversee audits, and collaborate with investigators, sponsors, and external partners.

The role requires a Bachelor's degree and 3+ years in regulatory affairs with supervisory experience, plus strong knowledge of FDA and GCP guidelines.

Qualifications

• Bachelor’s Degree or higher in a scientific field.
• Knowledge of scientific and clinical terminology.
• Experience in regulatory affairs ( minimum 3 years).
• Experience in supervisory role (minimum 1 year).
• Familiarity with FDA and GCP guidelines.

Responsibilities

• You will oversee all aspects of regulatory operations for SCRI and manage the Regulatory Department.
• Develop and implement strategies for regulatory compliance of Clinical Operations.
• Ensure FDA regulatory compliance and oversee regulatory audits.
• Collaborate with department directors, investigators, sponsors and external partners.
• Plan and schedule activities for the regulatory department.
• Establish procedures to ensure trial teams comply with laws, SOPs and guidelines.
• Develop and implement regulatory policies for site operations and Clinical Operations.
• Manage regulatory affairs across multiple trials per FDA and GCP guidelines.
• Foster relationships with industry partners and FDA; manage audits.
• Resolve regulatory issues with partners and government agencies.
• Develop and implement archiving system for study documents.
• Inform management of regulatory issues and obtain guidance.
• Attend meetings and provide training to regulatory staff.

Skills

Regulatory affairs

FDA guidelines

GCP guidelines

Leadership experience

Regulatory strategy

Education

Bachelor's Degree

Job description

It is 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.

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.

• You will be responsible for developing and implementing short- and long-term strategies for the regulatory compliance for the site Clinical Operations.
• You will ensure SCRI adheres to and maintains Food and Drug Administration (FDA) regulatory compliance as well as oversees any regulatory audit.
• You will work closely with the department directors and/or primary investigators, industry sponsors and other outside entities.
• You will manage, directs, plan and schedule activities and programs for the regulatory department.
• You will establish and enforce procedures that assure all trial teams and sites are fully compliant with all applicable laws, regulations, standard operating procedures (SOPs), and other applicable guidelines.
• You will develop and implement 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.
• You will manage the regulatory affairs between the organization for multiple clinical trials according to FDA and Good Clinical Practice (GCP) guidelines; for individual sites, studies, sponsors and/or other networks.
• You will manage 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.
• You will resolve key regulatory issues with Pharmaceutical Industry Partners and Government Agencies.
• You will develop and implement an approved archiving system for study specific regulatory documentation and correspondence.
• You will apprise management of important regulatory issues and obtains guidance when necessary.
• You will attend network meetings, conference calls and monthly staff meetings as appropriate.
• You will visit strategic sites and provides training and mentoring as needed.
• You will provide proactive and creative recommendations on how to meet goals and handle identified deviations.
• You will be responsible for objective setting, performance management, education and training of the regulatory staff, including developing Lead Regulatory Affairs Specialists.
• You will be responsible for implementing, managing, and refining departmental processes, and coordinating with clinical personnel around the conduct of research and client service issues.
• You will initiates improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects.

You should have for this position:

• 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 on year of experience in a supervisory role

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.

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.

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.

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.

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable.

Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people.