Regulatory Affairs Pharmacist

AP MAX INC•Houston, TX

5d•Remote

About The Position

Southend Pharmacy is seeking a dedicated and detail-oriented Regulatory Affairs Pharmacist. In this critical role, you will help ensure that our pharmacy operations remain compliant with all applicable laws, regulations, and professional standards. This position is highly specialized with a strong focus on quality assurance, risk management, and regulatory compliance. Your precision, accountability, and commitment to excellence will directly impact the safety and well-being of our patients. Remote opportunity within the state of Texas.

Requirements

PharmD or Bachelor of Pharmacy
Minimum of 5 years of experience as a pharmacist in a regulatory, compliance, or compounding environment
Strong understanding of healthcare regulations and sterile compounding best practices
Demonstrated experience monitoring and maintaining compliance with USP <795>, <797>, and <800>.
Strong knowledge of federal and state pharmacy laws and guidelines (FDA, DEA, HIPAA, TSBP)
Proven ability to identify compliance risks or deviations and recommend corrective actions
Proficiency with software programs (e.g. Pioneer, Google Workspace, Microsoft Excel/Word)
Experience in cleanroom or aseptic compounding practices for auditing purposes

Nice To Haves

Experience supporting compounding in a 503A or 503B specialty pharmacy setting
Hands-on experience developing, reviewing, and updating SOPs for compliance and compounding

Responsibilities

Conduct internal pharmacy audits to ensure compliance with state inspections and other accreditation agency reviews.
Identify and document compliance risks or deviations, preparing thorough discrepancy and incident reports.
Ensure documentation consistently meets requirements for audits and regulatory review.
Ensure adherence to federal and state pharmacy laws and regulations (FDA, DEA, HIPAA, state boards of pharmacy).
Monitor and maintain compliance with USP <795>, <797>, and <800> standards for compounding per assigned state guidelines.
Assist in developing, reviewing, and updating Standard Operating Procedures (SOPs).
Stay current on evolving pharmacy laws and regulations in assigned states, providing timely updates and education to staff.
Collaborate with management on incident reporting, root cause analysis, and corrective action plans.
Attend all state board of pharmacy meetings for assigned states to stay up to date with current regulations.
Complete all renewal paperwork for assigned states.
Ensure proper licensure and compliance for all assigned states.
Serve as the subject matter expert for assigned territory of states for all rules and regulations that govern those states.
Maintain accurate and up-to-date licensure records for pharmacists in assigned states.
Ensure compliance-related acknowledgments and training are tracked and documented for pharmacists in your assigned states.
Serve as a trusted point of contact for compliance-related questions or concerns.