Licensing Compliance Specialist

Licensing Compliance Specialist

Position Summary

Licensing Compliance Specialist (LCS) shall manage and support state licensing, licensing regulatory compliance, and accreditation activities for pharmaceutical distribution operations. LCS demonstrated expertise in multi-state licensing programs, regulatory renewals, compliance documentation, and interactions with Boards of Pharmacy and other regulatory agencies. This role is responsible for ensuring uninterrupted business operations through proactive license management, audit readiness, and regulatory compliance oversight. This position will serve as a key resource for licensing strategy, accreditation support, and process improvement initiatives.

LCS while responsible for all AvKARE and R&S Northeast licenses, bonds, and accreditations for all company facilities, they shall also act as a liaison between AvKARE / R&S and Parent Company, Amneal. They will ensure well times responses and deliverables and work to maintain good and effective relationships between the companies.

• Three (3) or more years of experience in pharmaceutical licensing, regulatory compliance, quality assurance, or related compliance functions.
• Working knowledge of pharmaceutical distribution licensing requirements, including wholesale distributor, manufacturer, and 3PL licensing.
• Experience coordinating multi-state license renewals and regulatory filings.
• Experience communicating directly with Boards of Pharmacy and regulatory agencies.
• Strong organizational skills with the ability to manage multiple projects and regulatory deadlines simultaneously.
• Proficiency with Microsoft Office Suite, including Excel, Word, and database management tools.
• Strong verbal and written communication skills.
• Demonstrated ability to work independently while collaborating effectively with cross-functional teams.

Essential Duties and Responsibilities

State Licensing & Regulatory Compliance

• Manage and maintain pharmaceutical distribution, virtual wholesaler, manufacturer, and 3PL licenses across multiple jurisdictions including bonds and state specific certifications for controls and other licenses that may be needed to operate.
• Coordinate initial applications, renewals, amendments, change-of-officer filings, facility relocations, and designated representative changes.
• Monitor licensing requirements and regulatory changes to ensure continued compliance with state and federal laws.
• Serve as the primary liaison with Boards of Pharmacy, regulatory agencies, designated representatives, and internal stakeholders within the company and Regulatory Affairs group.
• Maintain licensing records, regulatory filings, and supporting documentation in a centralized compliance management system.
• Track renewal schedules and ensure timely submission of required applications and fees.
• Report periodic updates to the executive staff and heads of Regulatory Affairs.

• Maintain audit-ready licensing and compliance files.
• Support internal compliance reviews, regulatory inspections, and accreditation assessments.
• Monitor compliance activities and escalate potential regulatory risks or deficiencies.
• Support corrective and preventive action (CAPA) initiatives related to licensing and regulatory compliance.

• Support NABP accreditation programs, including VAWD and other industry accreditation requirements.
• Assist with accreditation applications, surveys, renewals, and corrective action responses.
• Collaborate with Quality Assurance and Regulatory Affairs teams to maintain compliance standards and support all roles and responsibilities within the group.
• Participate in audit preparation and follow-up activities.

Process Improvement & Technology

• Maintain and improve licensing management databases and tracking systems.
• Identify opportunities to streamline workflows, improve data integrity, and enhance compliance efficiency.
• Develop reports and dashboards related to licensing status, renewals, and regulatory metrics.