50 State Pharmacist Director

Company: Elite AI Technologies
Location: Albany
Posted on: March 17, 2026

Job Description:

Job Description ABOUT THE COMPANY Galaxy Pharmaceuticals, LLC is an FDA-registered 503B outsourcing facility headquartered in Albany, NY, manufacturing sterile compounded preparations for hospitals, health systems, and clinics nationwide. Our facility features two ISO-classified sterile cleanroom suites with digital-first production documentation, barcode-driven traceability, and a formalized quality management system built to exceed cGMP expectations. As we prepare to deliver compounded sterile products across all 50 states, we need a seasoned regulatory pharmacy leader to build and manage our multi-state licensing and compliance infrastructure. POSITION SUMMARY The 50 State Pharmacist Director is a senior strategic and regulatory leadership role responsible for obtaining, maintaining, and ensuring continuous compliance with pharmacy licenses and registrations across all 50 states, the District of Columbia, and U.S. territories. This role serves as the organization's subject matter expert on state-by-state Board of Pharmacy requirements for 503B outsourcing facilities, including non-resident pharmacy licensing, product-specific registration, prescriber/entity eligibility rules, and controlled substance distribution permits. This is a high-impact, hybrid position: the director will work on-site at the Albany facility for regulatory inspections, quality system collaboration, and cross-functional planning, with remote flexibility for the substantial desk-based licensing, research, and state board correspondence workload. KEY RESPONSIBILITIES Multi-State Licensing and Registration Management • Develop and execute a 50-state licensing strategy: identify all required state pharmacy licenses, non-resident pharmacy permits, 503B facility registrations, and controlled substance distributor permits for each jurisdiction • Prepare, submit, and manage initial license applications, renewals, amendments, and supplemental filings for all state boards of pharmacy and relevant regulatory agencies • Maintain a centralized licensing database tracking application status, expiration dates, renewal deadlines, inspection schedules, and board correspondence for every jurisdiction • Monitor legislative and regulatory changes across all 50 states that impact 503B outsourcing facility operations, product eligibility, or distribution requirements State Board of Pharmacy Relations and Inspections • Serve as the primary point of contact for all state boards of pharmacy; manage inquiries, information requests, and formal correspondence • Coordinate and lead state board of pharmacy inspections (remote and on-site); prepare facility staff, assemble documentation packages, and manage post-inspection responses and corrective actions • Build and maintain professional relationships with state board executive directors, compliance officers, and inspectors nationwide • Track and interpret state-specific requirements for 503B product distribution, including formulary restrictions, prescriber eligibility, entity eligibility (hospital, clinic, surgery center), and labeling/reporting mandates Regulatory Compliance and Policy Development • Develop and maintain internal SOPs, policies, and reference guides governing multi-state regulatory compliance, ensuring alignment with FDA 503B guidance, state pharmacy practice acts, and DEA requirements • Advise executive leadership, sales, and operations teams on state-specific distribution restrictions, product eligibility, and go-to-market regulatory feasibility before entering new state markets • Ensure all marketing, labeling, and distribution activities comply with jurisdiction-specific requirements; serve as the regulatory gatekeeper for new state market launches • Collaborate with QA to ensure state-specific reporting obligations (adverse events, product recalls, complaint notifications) are met within required timelines Controlled Substance Licensing and DEA Coordination • Obtain and maintain state-level controlled substance manufacturing, distribution, and dispensing permits as required per jurisdiction • Coordinate with the DEA for federal registration and ensure state CS permits align with DEA registration requirements • Monitor state-specific controlled substance reporting requirements (PDMP reporting, Schedule II-V distribution rules) and ensure operational compliance Cross-Functional Collaboration • Partner with Sales and Business Development to prioritize state licensing based on market opportunity, hospital/health system demand, and revenue targets • Work with Quality Assurance on inspection readiness, deviation/CAPA inputs related to state regulatory findings, and annual product review requirements • Collaborate with Operations to ensure production, labeling, and shipping workflows accommodate state-specific requirements (e.g., state-specific labeling, reporting, or storage mandates) • Support Legal and Compliance on regulatory risk assessments, board enforcement actions, and pharmacy law interpretation Reporting, Analytics, and Executive Communication • Provide monthly executive dashboards on licensing status, upcoming deadlines, state regulatory changes, and market access progress across all jurisdictions • Develop and present state market readiness assessments to leadership prior to commercial distribution in new states • Maintain audit-ready documentation for all licensing activities; support FDA and state inspections with licensing records as required REQUIRED QUALIFICATIONS • Pharm.D. or B.S. in Pharmacy; active, unrestricted pharmacist license in New York State (additional state licenses a plus) • 7 years of experience in pharmacy regulatory affairs, multi-state licensing, or pharmacy compliance, with at least 3 years focused on 503B outsourcing, sterile compounding, or pharmaceutical manufacturing/distribution • Demonstrated experience managing pharmacy licenses across 20 states (50-state experience strongly preferred) • Deep knowledge of state boards of pharmacy regulatory frameworks, non-resident pharmacy licensing requirements, and 503B-specific state regulations • Strong understanding of FDA 503B guidance, 21 CFR 210/211, USP / / , and DEA controlled substance regulations as they intersect with state requirements • Exceptional organizational skills with proven ability to manage complex, multi-jurisdictional deadlines and regulatory portfolios • Outstanding written and verbal communication skills for regulatory correspondence, inspection responses, and executive presentations • Proficiency with licensing management databases/software and Microsoft Office Suite PREFERRED QUALIFICATIONS • Prior experience building a 50-state licensing program from the ground up for a 503B outsourcing facility or pharmaceutical manufacturer/distributor • Established relationships with state board of pharmacy officials nationwide • Experience with state legislative tracking and regulatory intelligence platforms (e.g., LexisNexis State Net, MultiState, NABP resources) • Knowledge of GPO/IDN contracting requirements that intersect with state licensing (Vizient, Premier, HealthTrust) • RAC (Regulatory Affairs Certification) or similar professional credential • Experience managing outside regulatory counsel or licensing service vendors across multiple states WORK ARRANGEMENT • Hybrid: Combination of on-site work at 15 Walker Way, Albany, NY 12205 and remote work • On-site presence required for state board inspections, regulatory audits, cross-functional planning sessions, and quality system collaboration • Remote flexibility for licensing research, application preparation, state board correspondence, and regulatory monitoring • Travel: Up to 15-20% for state board meetings, industry conferences (NABP, ASHP), and multi-state inspection coordination COMPENSATION AND BENEFITS • Competitive salary commensurate with experience; performance-based annual bonus tied to licensing milestones and market access targets • Medical, dental, and vision insurance; 401(k) with company match • Generous PTO, paid holidays, CE reimbursement, and licensure fee reimbursement (all states) • Life/disability insurance, home office stipend, and relocation assistance (if applicable) • Conference attendance support (NABP Annual Meeting, ASHP Midyear, state pharmacy association events) WHY GALAXY PHARMACEUTICALS? • Strategic Impact: Build the entire multi-state regulatory infrastructure from the ground up and directly enable nationwide market access • Mission-Driven: Every license you secure opens access to critical compounded medications for hospitals and patients who need them • Hybrid Flexibility: Balance on-site regulatory collaboration with remote work suited to licensing and research workloads • Growth: Join a rapidly expanding organization where regulatory excellence is a core competitive advantage Galaxy Pharmaceuticals, LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Apply with resume, cover letter, and a summary of your multi-state licensing experience.

Keywords: Elite AI Technologies, Albany , 50 State Pharmacist Director, Healthcare , Albany, New York