Director, Regulatory Affairs & DSCSA Strategy

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

Job summary

McKesson Corporation seeks a Director of Regulatory Affairs to lead Licensure, Trade Compliance, and DSCSA programs for a multi‑facility 3PL. You will establish regulatory strategy, governance, and risk controls, partnering with Quality, Legal, Compliance, Operations, IT, and Finance.

Hybrid role with ~25% travel. Reporting to the VP of Quality Assurance and Regulatory Affairs, you will lead a team of regulatory professionals, advocate for compliance, and deliver executive‑level risk assessments

Qualifications

• Bachelor level degree or equivalent in regulatory/related field.
• 10+ years in pharmaceutical regulatory affairs, quality, compliance, distribution, or regulated environment.
• 5+ years of people leadership or program leadership experience.
• Deep knowledge of pharmaceutical distribution requirements, DSCSA, and risk management.
• Experience leading cross-functional initiatives with regulators, auditors, and senior leaders.
• Ability to translate complex requirements into practical controls and governance.

Responsibilities

• Develop and execute the 3PL regulatory affairs strategy for Licensure, Trade Compliance, and DSCSA.
• Own the regulatory risk framework including identification, assessment, control design, monitoring, escalation, and remediation.
• Provide independent regulatory judgment and clear recommendations when agency expectations diverge from operations.
• Establish governance, escalation thresholds, and risk-acceptance pathways for material issues.
• Deliver executive‑level assessments of regulatory exposure, business impact, and recommended actions.
• Lead, coach, and develop a team of 3–4 regulatory professionals.

Skills

Regulatory risk management

Cross‑functional leadership

Regulatory assessments

Executive‑level communication

Governance & escalation

Strategic regulatory planning

Regulatory compliance

Ambiguity management

Education

Bachelor's degree or equivalent in Regulatory Affairs, Pharmacy, Life Sciences, Business Administration, Supply Chain Management, or related field

Regulatory Affairs Certification (RAC)

Advanced degree (PharmD/JD/MBA/MS)

Tools

None

Job description

McKesson Corporation seeks a Director of Regulatory Affairs to lead Licensure, Trade Compliance, and DSCSA programs for a multi‑facility 3PL. You will establish regulatory strategy, governance, and risk controls, partnering with Quality, Legal, Compliance, Operations, IT, and Finance.

Hybrid role with ~25% travel. Reporting to the VP of Quality Assurance and Regulatory Affairs, you will lead a team of regulatory professionals, advocate for compliance, and deliver executive‑level risk assessments