Senior Regulatory Affairs Specialist

🔥 19 hours ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Coordinate physicians’ and clinical teams’ activities related to creating and maintaining essential regulatory documents • Ensure compliance with regulatory requirements • 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 • Create and maintain essential regulatory documents for assigned studies • Complete regulatory documents on time to meet department and sponsor timelines • Maintain updated physician credentials • Modify and/or develop informed consent forms • Manage protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA • Work closely with regulatory affairs management, the department director, and/or primary investigators • Improve regulatory processes and manage multiple tasks while meeting strict deadlines • Carry an expanded study workload with little to no supervision

🎯 Requirements

• Minimum High School Diploma/GED obtained • Bachelor’s Degree or equivalent combination of education and experience may be substituted • Minimum 3 years’ work experience in the Regulatory Affairs Specialist role • Strong knowledge of scientific and clinical research terminology • Knowledge of IRB, FDA, and GCP guidelines • SOCRA Certification and/or ACRP Certification highly preferred • US-based work authorization/location required; visa sponsorship is not available

🏖️ Benefits

• Comprehensive benefits supporting physical, mental, and financial well-being • Annual bonus or long-term incentive opportunities may be offered • Relocation assistance is not available • Visa sponsorship is not available