Manager of Regulatory Affairs - Remote US
Sarah Cannon Research Institute•Usa, TN
•Remote
About The Position
The Regulatory Affairs Manager oversees regulatory operations for Sarah Cannon Research Institute (SCRI) site Clinical Operations and manages the regulatory department. The role develops and implements short- and long-term strategies for regulatory compliance, ensures adherence to FDA requirements, and oversees regulatory audits. The manager works closely with department directors, primary investigators, industry sponsors, and other external entities. This is a remote position based in the United States; relocation assistance and visa sponsorship are not available.
Requirements
- Bachelor's degree.
- At least 1 year of work experience; education may be substituted for part of the experience requirement.
- Knowledge of scientific and clinical research terminology.
- Knowledge of FDA and GCP guidelines.
- Knowledge of organizational policies, procedures, and systems.
- Advanced skills with Microsoft Office products, including Excel, Word, and Outlook.
- Experience meeting strict deadlines and supervising team members.
Nice To Haves
- Five or more years of experience in a clinical research corporation and regulatory team.
Responsibilities
- Manage, direct, plan, and schedule activities and programs for the regulatory department.
- Establish and enforce procedures to ensure trial teams and sites comply with applicable laws, regulations, SOPs, and other guidelines.
- Develop and implement regulatory policies and procedures for sites and the site Clinical Operations team.
- Manage and plan regulatory affairs compliance for industry sponsors and sites.
- Manage regulatory affairs across multiple clinical trials in accordance with FDA and GCP guidelines for individual sites, studies, sponsors, and networks.
- Manage relationships between industry partners and the FDA regarding organizational regulatory compliance.
- Manage regulatory audits of studies conducted by sponsors, industry, and governmental auditors.
- Perform other duties as assigned.
Benefits
- Comprehensive benefits supporting physical, mental, and financial well-being.
- Competitive compensation package.
- Potential annual bonus or long-term incentive opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
