Director, Regulatory Affairs & Enterprise Risk

McKesson Corporation; Shepherdsville (KY); Hybrid; USD 118,000 - 197,000; Full time

Benefits offered by this job

Hybrid work schedule

Competitive compensation

Long-term incentive opportunities

Job summary

McKesson Corporation seeks a Director of Regulatory Affairs to provide strategic leadership for Licensure, Trade Compliance, and DSCSA within a large 3PL organization. You will own regulatory risk, establish governance, and guide executive decisions.

The role leads a team of regulatory professionals, partners with Quality, Legal, Compliance, and Operations, and acts as the enterprise regulatory authority for assigned programs. Hybrid work and significant experience are required.

Qualifications

• Bachelor's degree or equivalent in Regulatory Affairs, Pharmacy, Life Sciences, Business Administration, or related field.
• 10+ years of progressive experience in pharmaceutical regulatory affairs, quality, compliance, distribution, or another highly regulated environment.
• 5+ years of people leadership or significant program leadership experience.
• Demonstrated knowledge of pharmaceutical distribution requirements, DSCSA, and regulatory risk management.
• Experience leading cross-functional initiatives and interacting with regulators, auditors, customers, legal counsel, and senior leaders.

Responsibilities

• Develop and execute the 3PL regulatory affairs strategy for Licensure, Trade Compliance, and DSCSA, aligned with objectives and risk appetite.
• Own the regulatory risk framework for assigned programs, including risk identification, assessment, control design, monitoring, escalation, remediation.
• Provide executive leadership with timely, decision-ready assessments of regulatory exposure and actions.
• Lead, coach, and develop a team of regulatory affairs professionals (approx. 3–4).
• Serve as a senior company representative during regulatory inspections, inquiries, audits, and significant engagements.
• Lead governance and escalation thresholds for material regulatory issues and ensure remediation plans.

Skills

Regulatory affairs

Leadership

Risk management

Strategic thinking

Cross-functional

Regulatory inspections

Education

Bachelor's degree

Regulatory Affairs certification

Job description

McKesson Corporation seeks a Director of Regulatory Affairs to provide strategic leadership for Licensure, Trade Compliance, and DSCSA within a large 3PL organization. You will own regulatory risk, establish governance, and guide executive decisions.

The role leads a team of regulatory professionals, partners with Quality, Legal, Compliance, and Operations, and acts as the enterprise regulatory authority for assigned programs. Hybrid work and significant experience are required.