Regulatory Affairs Lead: Complex Molecules & REMS

McKesson Corporation; Mason (OH); On-site; USD 77,000 - 128,000; Full time

Job summary

McKesson Corporation is seeking a Regulatory Affairs Manager (P3) to lead regulatory compliance for complex molecules, REMS, and restricted distribution within pharmaceutical logistics. You will translate requirements into practical controls, support onboarding and change management, and partner with QA, Licensing, Legal, and Operations.

The role requires regulatory expertise across FDA, DEA, and state boards, with a focus on ensuring inspection readiness and risk-based decision making in a

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Regulatory Affairs Certification (RAC) or equivalent.
• Experience interpreting regulatory requirements for pharma distribution.

Responsibilities

• Provide regulatory oversight for complex molecules and REMS, ensuring compliant operations.
• Translate regulatory requirements into scalable processes, SOPs, and training.
• Collaborate with QA, Operations, Licensing, Legal, and Commercial teams to support product lifecycle.

Skills

Regulatory affairs

FDA/DEA compliance

Pharma distribution

Risk assessment

Cross-functional leadership

Education

Bachelor's degree in Life Sciences

Regulatory Affairs Certification (RAC)

Job description

McKesson Corporation is seeking a Regulatory Affairs Manager (P3) to lead regulatory compliance for complex molecules, REMS, and restricted distribution within pharmaceutical logistics. You will translate requirements into practical controls, support onboarding and change management, and partner with QA, Licensing, Legal, and Operations.

The role requires regulatory expertise across FDA, DEA, and state boards, with a focus on ensuring inspection readiness and risk-based decision making in a