Southend Pharmacy · 2 hours ago
Regulatory Affairs Pharmacist (Remote)
United States
Full-time
Remote
Senior Level
$110K/yr - $130K/yr
5+ years expSouthend Pharmacy is a modern 503A compounding pharmacy focused on clinical precision and operational clarity. The Regulatory Affairs Pharmacist will ensure compliance with laws and regulations for pharmacy operations, acting as the primary Subject Matter Expert for state-specific licensure and renewals.
Retail
No H1B
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
Qualification
Required
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
Preferred
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
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.
Company
Southend Pharmacy
Southend Pharmacy is a state-licensed 503A compounding pharmacy supporting patient-specific care through personalized formulations and thoughtful collaboration with healthcare providers.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase