Regulatory Affairs Specialist: Complex Molecules & REMS

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

Job summary

McKesson is seeking a Regulatory Affairs Manager (P3) for Complex Molecules & Specialized Distribution Programs to ensure regulatory compliance across distribution operations. You will translate requirements from FDA, DEA, state boards, and manufacturers into practical controls and procedures, and support onboarding and change management for complex therapies.

The role emphasizes collaboration with QA, Operations, Licensing, Legal, and external partners to sustain inspection readiness, mitigate

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, Supply Chain, Healthcare Administration, or related field.
• 3-5 years of regulatory affairs or related experience.
• Experience translating regulatory requirements into operational controls.
• Experience with pharmaceutical distribution or 3PL operations.
• Regulatory Affairs Certification (RAC) or equivalent credential.

Responsibilities

• Serve as regulatory resource for complex molecules and programs.
• Assess obligations involving FDA, DEA, state pharmacy, manufacturer and quality requirements.
• Translate requirements into scalable operational controls and monitoring.
• Identify conflicts and dependencies where multiple requirements apply.
• Evaluate changes for regulatory impact and recommend risk controls.
• Lead regulatory guidance and training for internal stakeholders.

Skills

Regulatory compliance

Analytical skills

Technical writing

Documentation

Problem-solving

Communication

Education

Bachelor's degree

Job description

McKesson is seeking a Regulatory Affairs Manager (P3) for Complex Molecules & Specialized Distribution Programs to ensure regulatory compliance across distribution operations. You will translate requirements from FDA, DEA, state boards, and manufacturers into practical controls and procedures, and support onboarding and change management for complex therapies.

The role emphasizes collaboration with QA, Operations, Licensing, Legal, and external partners to sustain inspection readiness, mitigate