The Director of Regulatory Compliance provides regulatory leadership for the Philadelphia distribution operation, ensuring adherence to all applicable federal, state, and accreditation requirements governing pharmaceutical wholesale distribution activities at the site level.
This role oversees the development, implementation, and continuous improvement of compliance programs related to DEA controlled substance monitoring, FDA regulatory requirements, state boards of pharmacy regulations, and NABP accreditation standards specific to the Philadelphia distribution facility.
The Director serves as the primary regulatory authority for the Philadelphia facility and advises leadership on regulatory risks, compliance trends, and inspection readiness. This position also provides leadership and oversight to the Compliance Manager responsible for day-to-day compliance monitoring activities, with responsibility for mentoring and developing the role to strengthen regulatory expertise and compliance program execution within the organization.
Essential Duties and Responsibilities
Regulatory Authority & Compliance Leadership
- Serve as the designated Compliance Officer for the Philadelphia distribution operation, providing leadership and oversight for regulatory compliance programs governing pharmaceutical distribution activities.
- Act as the primary regulatory authority for the facility, ensuring adherence to applicable DEA, FDA, OSHA, state regulatory agencies, and NABP accreditation requirements.
- Oversee governance and administration of the company’s ARCOS reporting program for the Philadelphia operation, ensuring accurate reporting and compliance with DEA regulatory requirements.
- Provide leadership oversight for recall processes and regulatory responses impacting the Philadelphia facility.
Regulatory Inspection & Audit Leadership
- Lead preparation and coordination for regulatory inspections and compliance audits conducted by agencies including the DEA, FDA, state boards of pharmacy, and NABP accreditation organizations.
- Serve as the primary internal point of coordination during regulatory inspections and oversee communication with regulatory authorities as appropriate.
- Oversee and coordinate internal and external compliance audits, including those associated with regulatory inquiries, operational reviews, and audits
- Ensure audit findings and regulatory observations are communicated to leadership and that appropriate corrective and preventative actions are implemented.
Compliance Governance & Policy Management
- Oversee the development, revision, and dissemination of compliance policies, standards, and procedures applicable to the Philadelphia location to ensure alignment with regulatory requirements and company expectations.
- Evaluate the effectiveness of site-level compliance policies and internal controls and recommend improvements to address regulatory developments or operational changes.
- Facilitate consistent implementation of compliance policies and procedures across the Philadelphia operation.
Controlled Substance Compliance Oversight
- Provide governance and oversight of Suspicious Order Monitoring Program (SOMP) and controlled substance compliance framework.
- Oversee customer due diligence processes, including DEA questionnaires and controlled substance purchasing reviews, to ensure regulatory compliance and appropriate customer authorization.
- Provide oversight of monitoring activities used to evaluate customer purchasing patterns and identify potential suspicious order activity.
- Collaborate with Sales and operational teams to ensure controlled substance monitoring requirements are understood and followed.
Compliance Program Management
- Oversee compliance-related programs supporting the Philadelphia operation, including regulatory training, serialization (DSCSA), compliance monitoring and reporting, disaster recovery, contingency planning, and record retention programs.
- Ensure appropriate compliance controls and monitoring processes are implemented and maintained to support regulatory adherence.
Regulatory Advisory & Cross-Functional Partnership
- Monitor regulatory developments and advise management regarding new or pending laws and regulations that may impact company operations.
- Partner with internal departments to ensure operational practices align with regulatory requirements, particularly related to new or revised products, services, or distribution activities.
- Provide regulatory guidance and consultation to operational teams regarding compliance obligations and regulatory expectations.
Licensing & Regulatory Coordination
- Coordinate with the parent company’s regulatory and licensing teams to support licensing applications, renewals, and regulatory filings affecting the Philadelphia facility.
- Provide documentation, operational information, and compliance validation required for regulatory submissions.
- Ensure operational practices remain aligned with applicable licensing conditions governing pharmaceutical wholesale distribution.
Compliance Risk Management
- Identify and assess regulatory risks associated with distribution activities and compliance programs.
- Implement mitigation strategies and compliance controls designed to reduce regulatory exposure and maintain regulatory readiness.
- Escalate significant regulatory risks or compliance concerns to executive leadership when appropriate.
Leadership & Team Development
- Provide leadership and oversight to the Compliance Manager supporting the Philadelphia compliance function.
- Mentor and develop the Compliance Manager to strengthen regulatory expertise, compliance program execution, and inspection readiness.
- Review and validate compliance monitoring activities conducted by the Compliance Manager to ensure alignment with regulatory expectations and company standards.
Compliance Reporting & Program Accountability
- Inform and advise leadership regarding regulatory compliance matters, inspection outcomes, and emerging regulatory risks affecting the organization.
- Monitor the effectiveness of compliance programs and implement improvements necessary to maintain inspection readiness and regulatory compliance integrity.
- Ensure compliance programs support operational accountability and align with regulatory expectations governing pharmaceutical distribution activities.
Job Requirements
Education
- Bachelor’s degree in Regulatory Affairs, Pharmacy, Healthcare Administration, Law or related field from an accredited college or university, or equivalent combination of education and relevant experience.
Experience
- 10+ years of regulatory compliance experience in pharmaceutical distribution, healthcare compliance, regulatory affairs, or a related field.
- Minimum 5 years of leadership or supervisory experience.
- Experience managing regulatory inspections, compliance programs, and regulatory audits.
Knowledge Requirement
- DEA controlled substance regulations
- FDA regulatory requirements
- State board of pharmacy regulations
- NABP accreditation standards
- Suspicious Order Monitoring Programs (SOMP)
- Pharmaceutical wholesale distribution compliance requirements
Skills & Competencies
- Regulatory compliance leadership
- Risk management and regulatory interpretation
- Cross-functional collaboration
- Executive communication and regulatory reporting
- Team development and coaching
- Compliance program governance
Other Requirements
- Ability to pass DEA and background screening requirements as applicable.
- Ability to communicate effectively with regulatory agencies, external partners, and internal stakeholders.
Travel
Must be willing to travel as needed for regulatory inspections, training, conferences, or company meetings.
Benefits:
- Competitive salary and bonus structure
- Comprehensive health, dental, and retirement plans
- Ongoing professional development opportunities
- A dynamic and collaborative work environment
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Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required for this job. Duties, responsibilities, and activities may change at any time with or without notice.
AvKare/R&S Northeast is an Equal Opportunity Employer and we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.