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

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 organizations 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 organizations 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

• Bachelors 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.