Regulatory Affairs Specialist: Complex Molecules & REMS

McKesson; Shepherdsville (KY); On-site; USD 77,000 - 128,000; Full time

Job summary

McKesson is seeking a Regulatory Affairs Manager (P3) to lead regulatory compliance for complex molecules, REMS programs, and restricted-distribution products across pharmaceutical logistics. You will translate regulatory requirements into scalable operational controls and collaborate with QA, Licensing, Legal, and Operations to ensure audit readiness.

The role focuses on complex therapies, including biologics and cell therapies, with responsibility for product onboarding, change management, and

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, Supply Chain, Healthcare Administration, or a related field; equivalent experience may be considered.

Responsibilities

• Provide regulatory oversight for complex molecules and specialized distribution programs.
• Assess and translate regulatory obligations from FDA/DEA/state boards into operational controls.
• Support REMS and restricted-distribution compliance.
• Assist with regulated product onboarding, change management, and documentation.
• Coordinate audits, investigations, and corrective actions across functions.
• Communicate regulatory guidance and train internal stakeholders.

Skills

Regulatory compliance

Regulatory interpretation

Risk assessment

Technical writing

Cross-functional collaboration

Communication skills

Project management

Quality assurance

Investigation

Documentation

Education

Bachelor's degree in Life Sciences/Pharmacy/Regulatory Affairs

RAC or equivalent credential

Tools

Microsoft Office

Document management tools

Job description

McKesson is seeking a Regulatory Affairs Manager (P3) to lead regulatory compliance for complex molecules, REMS programs, and restricted-distribution products across pharmaceutical logistics. You will translate regulatory requirements into scalable operational controls and collaborate with QA, Licensing, Legal, and Operations to ensure audit readiness.

The role focuses on complex therapies, including biologics and cell therapies, with responsibility for product onboarding, change management, and