Job Details

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 jurisdictions.

• 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 facilities, expansions, acquisitions, reorganizations, new services, operational changes, and customer implementations.

• Maintain risk-based visibility to license status, renewal timeliness, regulatory commitments, dependencies, and exceptions across the network.

• Define controls to prevent regulated activity from occurring outside the scope or effective dates of required authority.

DSCSA Compliance Leadership

• Provide strategic oversight and risk ownership for the enterprise DSCSA compliance program.

• Ensure governance for product tracing, electronic interoperable exchange, verification, saleable returns, suspect and illegitimate product investigations, recordkeeping, and applicable notifications or reporting.

• Partner with Information Technology, Operations, Quality, customers, and trading partners to establish compliant and resilient serialization and traceability capabilities.

• Direct the evaluation and implementation of applicable statutes, FDA guidance, enforcement policies, industry standards, and emerging interoperability expectations.

• Ensure exceptions, system failures, data-quality issues, and trading-partner risks are assessed, contained, escalated, and remediated using documented risk-based processes.

• 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

• Lead the regulatory governance of trade compliance activities supporting domestic and international movement of pharmaceutical and healthcare products.

• 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.

• Partner with Legal, Compliance, Operations, Finance, brokers, freight forwarders, and customers to clarify accountability and resolve complex trade-compliance issues.

• Assess the regulatory implications of new trade lanes, countries of origin, product categories, business models, service offerings, and customer requirements.

• Monitor material exceptions and trends and ensure corrective actions address both immediate events and underlying systemic causes.

• Escalate trade compliance risks that may affect product movement, customer commitments, financial exposure, or regulatory standing.

People and Organizational Leadership

• Lead, coach, and develop a team of approximately 3-4 regulatory affairs professionals, establishing clear accountability, priorities, and performance expectations.

• Build organizational capability through talent development, cross-training, succession planning, and disciplined workload and resource management.

• Foster a culture of regulatory integrity, constructive challenge, timely escalation, practical problem-solving, and continuous improvement.

• Ensure the team maintains the technical knowledge, business acumen, systems proficiency, and stakeholder relationships required to execute assigned programs effectively.

• Manage external consultants or service providers, as appropriate, and ensure clear deliverables, accountability, and oversight.

Cross-Functional Leadership and Business Enablement

• Lead regulatory assessments for new customers, services, facilities, technologies, system changes, acquisitions, and strategic initiatives.

• 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.

• Support customer due diligence, audits, proposals, contracting discussions, and implementation planning by providing accurate regulatory requirements and risk-based recommendations.

• Influence stakeholders without direct authority and resolve conflicts between compliance obligations, operational constraints, customer expectations, and commercial objectives.

• Communicate complex regulatory matters in concise, decision-oriented terms appropriate for executives, customers, operational teams, and regulators.

Monitoring, Assurance, and Continuous Improvement

• Establish meaningful key risk indicators, key performance indicators, management review mechanisms, and reporting for assigned programs.

• Assess program effectiveness through trends, exception data, audits, regulatory developments, control testing, and stakeholder feedback.

• Ensure regulatory gaps, audit findings, agency observations, and recurring exceptions are assigned, tracked, remediated, and verified for effectiveness.

• Maintain an enterprise regulatory horizon-scanning process and ensure emerging requirements are assessed, prioritized, resourced, and implemented in a controlled manner.

• Drive simplification, standardization, automation, and process improvements without weakening regulatory control or accountability.

Decision Authority and Escalation

• Authorized to interpret assigned regulatory requirements and establish 3PL program standards, subject to Legal consultation where appropriate.

• Authorized to require risk assessments, corrective actions, control enhancements, and documented remediation plans within assigned program scope.

• Authorized to escalate material or unresolved risk directly to senior Quality, Regulatory, Compliance, Legal, Operations, or executive leadership.

• Expected to recommend operational restrictions, implementation holds, or other interim controls when regulatory compliance or product traceability cannot be reasonably assured.

• Does not unilaterally accept material enterprise risk outside delegated authority; ensures such decisions are documented and made by the accountable business or executive owner with appropriate Regulatory, Quality, Legal, and Compliance input.

Qualifications

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

• 10 or more years of progressive experience in pharmaceutical regulatory affairs, quality, compliance, distribution, supply chain, or another highly regulated environment.

• 5 or more years of people leadership or significant program leadership experience, including accountability for complex regulatory or compliance programs.

• Demonstrated knowledge of pharmaceutical distribution requirements, state licensing frameworks, DSCSA, and regulatory risk management.

• Experience leading cross-functional initiatives and interacting with regulators, auditors, customers, legal counsel, and senior leaders.

• Demonstrated ability to convert complex requirements into practical controls, governance, metrics, and executive-level recommendations.

• Ability to travel approximately 25% and work effectively in a hybrid environment.

Preferred Qualifications

• Advanced degree such as PharmD, JD, MBA, MS, or a related discipline.

• Experience in pharmaceutical wholesale distribution, third-party logistics, manufacturing, or healthcare supply chain operations.

• Deep experience with multi-jurisdictional licensure, DSCSA serialization and traceability, and trade compliance programs.

• Experience overseeing regulatory programs across multiple facilities, legal entities, or operating models.

• Regulatory Affairs Certification (RAC), Certified Customs Specialist (CCS), Licensed Customs Broker, or other relevant professional credential.

Work Environment and Travel

This position operates on a hybrid work schedule and requires approximately 25% travel to company facilities, customer locations, regulatory meetings, industry events, and other business locations. The role requires the ability to collaborate across functions, facilities, and time zones and to respond to significant regulatory events as business needs require.