Director, Regulatory Affairs (Licensure, DSCSA, and Trade Compliance Programs)
Description
McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care.
What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.
Position Summary
The Director, Regulatory Affairs provides strategic leadership, enterprise governance, and regulatory risk ownership for the Licensure, Trade Compliance, and Drug Supply Chain Security Act (DSCSA) programs supporting a large, multi-facility pharmaceutical third-party logistics (3PL) organization. The Director is accountable for establishing the regulatory strategy, control framework, decision rights, and escalation mechanisms necessary to maintain compliant operations while enabling sustainable business growth . The role reports to the VP, Quality Assurance and Regulatory Affairs.
This role serves as the enterprise regulatory authority for assigned programs and is responsible for identifying, assessing, communicating, accepting within delegated authority, mitigating, and escalating regulatory risk. The Director translates evolving federal and state requirements into durable business controls, advises executive leadership on material exposure and response options, and ensures that residual risk is transparent to the appropriate decision-makers. The position leads a team of regulatory professionals and partners closely with Quality, Legal, Compliance, Operations, Information Technology, Security, Finance, Customer Solutions, and Supply Chain leadership.
This Director owns the regulatory risk posture and control effectiveness of the assigned programs, with authority to require corrective action, elevate material risk, and recommend operational restrictions when compliance cannot be reasonably assured .
Key Responsibilities:
Regulatory Leadership and Risk Ownership
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Develop and execute the 3PL regulatory affairs strategy for Licensure, Trade Compliance, and DSCSA, aligned with business objectives , customer commitments, and the organization's risk appetite.
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Own the regulatory risk framework for assigned programs, including risk identification, assessment, control design, monitoring, escalation, remediation, and formal communication of residual risk.
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Exercise independent regulatory judgment and provide clear recommendations when legal requirements, agency expectations, operational realities, and industry practices are not fully aligned.
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Establish decision rights, governance forums, escalation thresholds, and documented risk-acceptance pathways for material regulatory issues.
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Provide executive leadership with timely, decision-ready assessments of regulatory exposure, business impact, alternatives, and recommended actions.
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Require corrective or preventive action when regulatory controls are ineffective and recommend suspension, limitation, or redesign of activities when compliance cannot be reasonably assured.
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Serve as a senior company representative during regulatory inspections, inquiries, audits, and significant customer or agency engagements involving assigned programs.
Licensure Program Oversight
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Direct 3PL licensure programs supporting multiple facilities, legal entities, service models, and regulated jurisdiction s.
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Ensure appropriate governance over state board of pharmacy, wholesale distributor, 3PL, controlled substance, and other applicable licensing obligations.
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Oversee licensing applications, renewals, amendments, change notifications, reporting obligations, and evidence retention.
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Assess and communicate licensure implications associated with new facilities, expansions, acquisitions, reorganizations, new services, operational changes, and customer implementations.
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Maintain risk-based visibility to license status, renewal timeliness, regulatory commitments, dependencies, and exceptions across the network.
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Define controls to prevent regulated activity from occurring outside the scope or effective dates of required authority.
DSCSA Compliance Leadership
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Provide strategic oversight and risk ownership for the enterprise DSCSA compliance program.
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Ensure governance for product tracing, electronic interoperable exchange, verification, saleable returns, suspect and illegitimate product investigations, recordkeeping, and applicable notifications or reporting.
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Partner with Information Technology, Operations, Quality, customers, and trading partners to establish compliant and resilient serialization and traceability capabilities.
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Direct the evaluation and implementation of applicable statutes, FDA guidance, enforcement policies, industry standards, and emerging interoperability expectations.
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Ensure exceptions, system failures, data-quality issues, and trading-partner risks are assessed, contained, escalated, and remediated using documented risk-based processes.
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Provide regulatory leadership for significant DSCSA events and determine when matters require escalation to executive leadership, customers, regulators, or legal counsel.
Trade Compliance Program Oversight
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Lead the regulatory governance of trade compliance activities supporting domestic and international movement of pharmaceutical and healthcare products.
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Oversee risk-based controls for import, export, customs, sanctions, classification, documentation, recordkeeping, and cross-border distribution obligations, as applicable to the organization's operating model.
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Partner with Legal, Compliance, Operations, Finance, brokers, freight forwarders, and customers to clarify accountability and resolve complex trade-compliance issues.
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Assess the regulatory implications of new trade lanes, countries of origin, product categories, business models, service offerings, and customer requirements.
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Monitor material exceptions and trends and ensure corrective actions address both immediate events and underlying systemic causes.
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Escalate trade compliance risks that may affect product movement, customer commitments, financial exposure, or regulatory standing.
People and Organizational Leadership
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Lead, coach, and develop a team of approximately 3-4 regulatory affairs professionals, establishing clear accountability, priorities, and performance expectations.
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Build organizational capability through talent development, cross-training, succession planning, and disciplined workload and resource management.
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Foster a culture of regulatory integrity, constructive challenge, timely escalation, practical problem-solving, and continuous improvement.
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Ensure the team maintains the technical knowledge, business acumen, systems proficiency, and stakeholder relationships required to execute assigned programs effectively.
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Manage external consultants or service providers, as appropriate, and ensure clear deliverables, accountability, and oversight.
Cross-Functional Leadership and Business Enablement
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Lead regulatory assessments for new customers, services, facilities, technologies, system changes, acquisitions, and strategic initiatives.
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Partner with Quality, Legal, Compliance, Operations, Information Technology, Security, Finance, Customer Solutions, and Supply Chain teams to embed regulatory requirements into business processes and system controls.
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Support customer due diligence, audits, proposals, contracting discussions, and implementation planning by providing accurate regulatory requirements and risk-based recommendations.
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Influence stakeholders without direct authority and resolve conflicts between compliance obligations, operational constraints, customer expectations, and commercial objectives