Manager, Regulatory Affairs

🔥 0 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟢 Junior

🚔 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, direct, plan, and schedule activities and programs for the regulatory department • Establish and enforce procedures ensuring trial teams and sites comply with applicable laws, regulations, SOPs, and 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/or sites • Manage regulatory affairs for multiple clinical trials according to FDA and GCP guidelines • Manage relationships with industry partners and the FDA regarding regulatory compliance • Manage regulatory audits of studies by sponsors, industry, and governmental auditors • Work closely with department directors, primary investigators, industry sponsors, and external entities • Perform other duties as assigned

🎯 Requirements

• Bachelor's Degree • 1+ year work experience; 5+ years preferred in a 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, and Outlook • Experience meeting strict deadlines • Experience supervising team members • Must be based in the US • Relocation assistance and visa sponsorship are not available

🏖️ Benefits

• Comprehensive Total Rewards package supporting physical, mental, and financial well-being • Competitive compensation package • Annual bonus or long-term incentive opportunities may be offered • Benefits through parent company McKesson

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