Regulatory Affairs Specialist, Complex Molecules & REMS

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

Job summary

McKesson Corporation is seeking a Regulatory Affairs Manager (P3) for Complex Molecules & Specialized Distribution Programs to ensure regulatory compliance across pharmaceutical logistics. You will translate nuanced FDA/DEA requirements into practical, scalable operational controls and partner with Quality, Licensing, and Operations to support REMS and restricted-distribution products.

The ideal candidate will bring 3–5 years in regulatory affairs or related fields, experience with controlled

Qualifications

• Bachelor's degree in Life Sciences or related field; equivalent experience considered.
• Experience interpreting regulatory requirements and translating them into operational controls.
• Experience supporting pharmaceutical distribution, specialty pharmacy, or 3PL operations.

Responsibilities

• Provide regulatory oversight for complex molecules and distribution programs.
• Translate regulatory requirements into scalable operational controls and monitoring activities.
• Support REMS and restricted-distribution program requirements within distribution and fulfillment operations.
• Assist with investigations of compliance concerns and coordinate corrective actions across functions.
• Lead cross-functional efforts to launch and manage regulated products in a compliant manner.
• Monitor regulatory developments and assess impacts on products and processes.

Skills

Regulatory affairs

Quality assurance

Pharmaceutical distribution

Regulatory interpretation

Risk assessment

Communication

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Document management tools

Job description

McKesson Corporation is seeking a Regulatory Affairs Manager (P3) for Complex Molecules & Specialized Distribution Programs to ensure regulatory compliance across pharmaceutical logistics. You will translate nuanced FDA/DEA requirements into practical, scalable operational controls and partner with Quality, Licensing, and Operations to support REMS and restricted-distribution products.

The ideal candidate will bring 3–5 years in regulatory affairs or related fields, experience with controlled