Director, Regulatory Affairs (Licensure, DSCSA, and Trade Compliance Programs)

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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 .

Regulatory Leadership and Risk Ownership   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.   Own the regulatory risk framework for assigned programs, including risk identification, assessment, control design, monitoring, escalation, remediation, and formal communication of residual risk.   Exercise independent regulatory judgment and provide clear recommendations when legal requirements, agency expectations, operational realities, and industry practices are not fully aligned.   Establish decision rights, governance forums, escalation thresholds, and documented risk-acceptance pathways for material regulatory issues.   Provide executive leadership with timely, decision-ready assessments of regulatory exposure, business impact, alternatives, and recommended actions.   Require corrective or preventive action when regulatory controls are ineffective and recommend suspension, limitation, or redesign of activities when compliance cannot be reasonably assured.   Serve as a senior company representative during regulatory inspections, inquiries, audits, and significant customer or agency engagements involving assigned programs.   Licensure Program Oversight   Direct 3PL licensure programs supporting multiple facilities, legal entities, service models, and regulated jurisdiction s.   Ensure appropriate governance over state board of pharmacy, wholesale distributor, 3PL, controlled substance, and other applicable licensing obligations.   Oversee licensing applications, renewals, amendments, change notifications, reporting obligations, and evidence retention.   Assess and communicate licensure implications associated with new