Regulatory Affairs Pharmacist (Remote)

Key Responsibilities

• 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.
• Monitor and ensure strict adherence to federal and state pharmacy laws (FDA, DEA, HIPAA) and USP , , and standards for all assigned states.
• Congduct internal audits to identify compliance risks or deviations; prepare detailed reports and collaborate with management on root cause analysis and corrective action plans.
• Assist in the development, review, and updating of Standard Operating Procedures (SOPs) to ensure documentation consistently meets requirements for audits and regulatory reviews.
• Maintain accurate, up-to-date licensure records and track compliance-related training acknowledgments for pharmacists within assigned regions.
• Conduct deep-dive research into state-specific laws and provide thorough, accurate explanations to the compliance team to ensure ongoing operational compliance.

Qualifications

• 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 and ).
• Proficiency with Google Workspace (Sheets, Docs) or Microsoft Office Suite (Excel, Word).
• Exceptional accuracy, organization, and diligent communication skills.

Prior Experience

• 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, such 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.

Employment Type

• Full-time, Monday through Friday, 7:00 AM – 4:00 PM.