Regulatory Affairs Pharmacist

Company Overview

Southend Pharmacy is a modern 503A compounding pharmacy built on clinical precision, operational clarity, and a human-first approach. Licensed in 20+ states and focused on longevity-aligned therapeutics, we support providers and their patients with precision in compounding and transparent processes. Southend Pharmacy operates at the intersection of innovation, ambition, and clinical excellence—blending precision, clarity, and compassionate support to help providers deliver patient-centered, clinically guided care across every step of the treatment journey.

Job Summary

The Regulatory Affairs Pharmacist will be responsible for 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.

Key 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.

Qualifications

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.

Physical Requirements

• Ability to maintain a dedicated and secure home office environment suitable for handling sensitive regulatory data.
• Ability to sit for extended periods of time while working on a computer and attending virtual meetings.
• Ability to communicate effectively via phone, email, and video conferencing platforms.
• Ability to perform repetitive motions with hands and arms, suchs as typing.

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.

Southend Pharmacy is unable to offer visa sponsorship at this time. Candidates must be legally authorized to work in the United States without current or future sponsorship.

Equal Opportunity Employer Statement

Allia Health Group is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

If you have any questions or require accommodations during the application process, please contact recruiting@alliahealth.co.

Key skills/competency

• Regulatory Compliance
• Pharmacy Law
• USP Standards
• Compounding Pharmacy
• Licensure Management
• Audit & Reporting
• SOP Development
• Healthcare Regulations
• DEA & FDA Compliance
• Pharmacist Expertise