Regulatory Affairs Coordinator

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Oversee and strategize regulatory affairs compliance for industry sponsors and/or sites within networks.

• Collaborate with regulatory affairs management, the department director, and/or primary investigators to ensure compliance.

• Prepare for auditing activities while adhering to stringent deadlines.

• Process requests for regulatory document signatures via an electronic signature platform.

• Monitor documents awaiting site regulatory signatures.

• Offer site-level regulatory assistance to Clinical Operations sites and internal department managers.

• Establish and uphold document management systems for both regulatory paper and electronic files.

• Maintain FDA and GCP-required regulatory documentation for individual sites, studies, sponsors, and/or networks.

• Ensure that regulatory documentation aligns with local SOPs regarding format and content.

• Keep physician credentials and other essential documentation up to date.

• Assess site requests for regulatory support and determine the appropriate pathway for issue resolution.

⛳️ Requirements

• An Associate Degree is required; a Bachelor’s Degree is preferred.

• Previous regulatory experience is preferred.

• Customer service experience is preferred.

• Familiarity with FDA and Good Clinical Practice (GCP) regulatory documentation.

• Ability to ensure that regulatory documentation adheres to local Standard Operating Procedures (SOPs).

• Capability to manage tight deadlines and prepare for auditing activities.

• Proficient in maintaining updated physician credentials and essential compliance documentation.

🏝️ Benefits

• Comprehensive benefits that support physical, mental, and financial well-being.

• Competitive compensation package.

• Annual bonus or long-term incentive opportunities may be available.

• Equity may be part of the compensation package.

• Total Rewards package.