Director, Regulatory Affairs – Controlled Substances & SOMS

McKesson Corporation; Mason (OH); On-site; USD 118,000 - 197,000; Full time

Job summary

McKesson is seeking a Director of Regulatory Affairs (Controlled Substances) to lead regulatory, operational, and security activities in a 3PL environment. You will oversee DEA registrations, SOMS, and the Due Diligence Program, serving as the primary liaison with DEA and state regulators and clients.

The role requires 12+ years in controlled substances with 5+ years in leadership, strong cross-functional collaboration, and a proven track record in audits and investigations.

Qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs, Supply Chain, or related field.
• 12+ years of experience in controlled substances in pharma, distribution, or 3PL operations, with 5+ years of people leadership.
• Expertise with DEA regulations, diversion-control systems, SOMS, and Due Diligence programs.
• Experience interacting directly with DEA inspectors and leading audits.
• Strong leadership, analytical, and cross-functional collaboration skills.

Responsibilities

• Lead the controlled substance compliance program across Import, Distribution, and Export activities.
• Oversee design and improvement of SOMS for compliant detection, escalation, and reporting of suspicious orders.
• Develop and maintain a Controlled Substance Due Diligence Program with onboarding, risk assessment, and documentation.

Skills

Regulatory leadership

DEA regulations

SOMS

Due Diligence

Cross-functional collaboration

Investigations

Education

Bachelor's degree in Life Sciences or Regulatory Affairs

Job description

McKesson is seeking a Director of Regulatory Affairs (Controlled Substances) to lead regulatory, operational, and security activities in a 3PL environment. You will oversee DEA registrations, SOMS, and the Due Diligence Program, serving as the primary liaison with DEA and state regulators and clients.

The role requires 12+ years in controlled substances with 5+ years in leadership, strong cross-functional collaboration, and a proven track record in audits and investigations.