Regulatory Affairs Coordinator

Job not on LinkedIn

🕒 October 9

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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McKesson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1833

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

McKesson is a diversified healthcare leader specializing in pharmaceutical distribution, medical supplies, and healthcare services. Their solutions facilitate patients' access to life-changing therapies, support efficient operations for pharmacies, health systems, and clinics, and address critical issues such as drug shortages through a resilient supply chain. McKesson provides comprehensive services such as pharmacy management software, consulting, and technology solutions for specialty practices, focusing on improving health outcomes and advancing the pharmaceutical industry. They work closely with biopharma companies to enhance medication access, adherence, and commercialization while supporting oncology and biopharma practices through data-driven insights and real-world evidence.

📋 Description

• Manage and plan regulatory affairs compliance for industry sponsors and/or sites in networks • Work with regulatory affairs management, department director, and/or primary investigators to ensure compliance • Prepare for auditing activities while meeting strict deadlines • Process regulatory document signature requests through an electronic signature platform • Track documents pending site regulatory signatures • Provide site-level regulatory support to Clinical Operations sites and internal department managers • Establish and maintain document management systems for regulatory paper and electronic files • Maintain FDA and GCP-required regulatory documentation for individual sites, studies, sponsors, and/or networks • Ensure regulatory documentation complies with local SOPs for format and content • Maintain updated physician credentials and other critical documentation • Triage site requests for regulatory support and identify the correct pathway for issue resolution

🎯 Requirements

• Associate Degree required; Bachelor’s Degree preferred • Regulatory experience preferred • Customer service experience preferred • Knowledge of FDA and Good Clinical Practice (GCP) regulatory documentation • Ability to ensure regulatory documentation complies with local Standard Operating Procedures (SOPs) • Ability to manage strict deadlines and prepare for auditing activities • Ability to maintain updated physician credentials and critical compliance documentation

🏖️ Benefits

• Comprehensive benefits supporting physical, mental, and financial well-being • Competitive compensation package • Annual bonus or long-term incentive opportunities may be offered • Equity may be included in compensation • Total Rewards package

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