Regulatory Affairs Pharmacist (Remote)

About the position The Regulatory Affairs Pharmacist will be responsible for but not limited to ensuring that pharmacy operations remain compliant with all applicable laws, regulations, and professional standards for an assigned regional territory. This role is the primary Subject Matter Expert (SME) for state-specific licensure, renewals, and board requirements, acting with a high degree of autonomy to safeguard the company’s ability to operate legally and safely across multiple jurisdictions. Responsibilities • State Board Management: Serve as the primary point of contact for an assigned region; attend all state board meetings, report on regulatory changes, and manage all pharmacy and controlled substance licensing renewals. • Compliance Oversight: Monitor and ensure strict adherence to federal and state pharmacy laws (FDA, DEA, HIPAA) and USP <795>, <797>, and <800> standards for all assigned states. • Facility Monitoring: Conduct internal audits to identify compliance risks or deviations; prepare detailed reports and collaborate with management on root cause analysis and corrective action plans. • SOP & Documentation: Assist in the development, review, and updating of Standard Operating Procedures (SOPs) to ensure documentation consistently meets requirements for audits and regulatory reviews. • Staff Compliance: Maintain accurate, up-to-date licensure records and track compliance-related training acknowledgments for pharmacists within assigned regions. • Independent Research: Conduct deep-dive research into state-specific laws and provide thorough, accurate explanations to the compliance team to ensure ongoing operational compliance. Requirements • Bachelor of Science in Pharmacy or PharmD. • Must hold an active and unencumbered Pharmacist license. • At least 5 years of experience as a Pharmacist with a focus on compliance, regulatory affairs, or cleanroom compounding. • Strong understanding of healthcare regulations and sterile compounding best practices (USP <797> and <800>) • Proficiency with Google Workspace (Sheets, Docs) or Microsoft Office Suite (Excel, Word). • Exceptional accuracy, organization, and diligent communication skills. Nice-to-haves • Recent experience working in or managing compliance for a cleanroom environment. • Experience in a 503A or 503B specialty pharmacy setting. • Familiarity with pharmacy audit software, quality tracking platforms, or compliance monitoring tools. • Residency in the assigned region (East Coast or West Coast) is a plus. Benefits • Salary Range: $110,000 - $130,000 annually. • Work Arrangement: Remote - US based. • Comprehensive benefits package including medical, dental, paid time off. • 401(k) retirement savings plan. • Eligible for quarterly bonus based on performance and departmental goals. • Ample opportunities for professional development and career growth. Apply tot his job Apply To this Job