Director, Regulatory Strategy & DSCSA Risk

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

Job summary

McKesson seeks a Director of Regulatory Affairs to lead Licensure, Trade Compliance, and DSCSA programs for a large 3PL pharmaceutical organization. The Director will establish regulatory strategy, governance, and risk ownership, reporting to the VP of Quality Assurance and Regulatory Affairs.

The role leads a regulatory team and partners with Quality, Legal, Compliance, Operations, IT, and Supply Chain to ensure compliant operations while enabling growth.

Qualifications

• Bachelor's degree or equivalent in Regulatory Affairs, Pharmacy, Life Sciences, Business Administration, Supply Chain Management, or related field.
• 10+ years of progressive experience in pharmaceutical regulatory affairs, quality, compliance, distribution, or a similarly regulated environment.
• 5+ years of people leadership or significant program leadership experience.
• Willingness to travel approximately 25% and work in a hybrid environment.

Responsibilities

• Lead regulatory strategy for Licensure, Trade Compliance, and DSCSA across multiple facilities.
• Manage the regulatory risk framework, monitoring, escalation, and remediation activities.
• Oversee licensure applications, renewals, amendments, change notifications, and reporting obligations.
• Lead a team of regulatory professionals (approximately 3-4) and partner with cross-functional teams.
• Collaborate with Legal, Compliance, Operations, Information Technology, Security, Finance, Customer Solutions, and Supply Chain to embed regulatory requirements into business processes.

Skills

Leadership

Regulatory affairs

Cross-functional collaboration

Regulatory risk management

Education

Bachelor's degree or equivalent in Regulatory Affairs/Pharmacy/Life Sciences/Business Admin/Supply Chain

Advanced degree (PharmD/JD/MBA/MS)

Job description

McKesson seeks a Director of Regulatory Affairs to lead Licensure, Trade Compliance, and DSCSA programs for a large 3PL pharmaceutical organization. The Director will establish regulatory strategy, governance, and risk ownership, reporting to the VP of Quality Assurance and Regulatory Affairs.

The role leads a regulatory team and partners with Quality, Legal, Compliance, Operations, IT, and Supply Chain to ensure compliant operations while enabling growth.