Licensing Specialist

The Licensing Specialist oversees corporate licenses and renewals for all CareTria warehouse facilities. The role tracks deadlines, prepares filings, coordinates with regulators, maintains records, and supports compliance research, audits, FDA and DEA registrations, NABP accreditation, and DSCSA reporting for 3PL and distribution operations. **Must reside within a commutable distance from the Lakewood, NJ offices. Onsite visits as required for the business needs.**

KEY RESPONSIBILITIES

Compliance Oversees federal and state distributor, pharmacy, 3PL, nonresident, and controlled substance license applications, renewals, amendments, and supporting documentation for all facilities. Maintains the licensing calendar, tracks deadlines, fees, and jurisdictional requirements, and issues advance reminders to prevent lapses. Communicates with regulators, resolves inquiries, monitors filing status, and serves as a liaison with state officials under management supervision. Research federal and state licensing requirements and regulatory changes, including DSCSA, PDMA, FDA, DEA, and 3PL rules; summarizes impacts and maintains a jurisdictional requirements matrix. Reports facility, ownership, name, operational, and designated representative changes within required timeframes. Supports Compliance inquiries, NABP reaccreditation, annual facility evaluations, licensing records, management projects, and payment requests. Registrations, Reporting & Accreditation Maintains FDA Drug Establishment and DEA/state- controlled substance registrations, including renewals, updates, and documentation. Compiles and supports timely annual DSCSA licensure reporting to FDA. Coordinates NABP accreditation documentation, corrective actions, surety bonds, and outside licensing providers. Verifies and documents client and trading partner licenses, registrations, and accreditations during onboarding and periodically thereafter; escalates expirations, discrepancies, and disciplinary actions. Audit & Inspection Support Provides licensing documentation for accreditation and client audits and supports state, FDA, and DEA inspection readiness. Tracks agency deficiencies and information requests through resolution and promptly escalates issues. Documentation & Administration Maintains complete, accurate, retrievable licensing records in accordance with documentation and retention requirements. Tracks licensing budgets, invoices, fees, and payment confirmations. The above duties are meant to be representative of the position and not all-inclusive.

MINIMUM JOB REQUIREMENTS

Bachelor's degree or 5–7 years of related compliance, licensing, or agency reporting experience; equivalent experience considered. Preferred Experience Pharmaceutical distribution or warehousing experience preferred. Two or more years of federal/state licensing or compliance experience in pharmaceutical wholesale distribution, 3PL, or another FDA-regulated warehouse environment. Experience with state board portals, license tracking systems, and NABP accreditation preferred. Notary Public certification is a plus.

KNOWLEDGE, SKILLS & ABILITIES

Knowledge of pharmaceutical distribution and federal/state requirements, including PDMA, DSCSA, FDA, DEA, and wholesale distributor and 3PL licensing standards. Understanding of licensing, registration, trading partner, FDA reporting, designated representative, surety bond, and controlled substance requirements. Ability to prepare submissions and maintain compliant electronic records under Good Documentation Practices, ALCOA+, and applicable 21 CFR Part 11 requirements. Strong research, analytical, communication, organizational, customer service, and attention-to-detail skills; able to manage deadlines, elevate issues, and maintain confidentiality. Proficient in Microsoft Office and able to learn business and warehouse systems.

PHYSICAL DEMANDS

Frequently required to sit and occasionally required to stand or walk; regularly uses a computer and standard office equipment for extended periods. Occasionally lifts and/or moves files or materials up to 10 lbs. May require occasional travel to warehouse/distribution facilities and support of audits or inspections, in person or remotely, as needed. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The expected base pay range for this position is $65,000-80,000 per year. The actual compensation for the position may vary based on market differences and on factors such as skills, experience, qualifications and can vary based on location and/or work schedule. In addition to base pay, CareTria offers a comprehensive benefits package. Full-Time benefits include access to health, dental, and vision insurance; retirement plan options; paid time off; paid parental leave; employee assistance programs; and other perks. Eligible employees may also have access to performance bonuses. CareTria is an Equal Opportunity Employer. #J-18808-Ljbffr CareTria