Role Description

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.

Key Responsibilities

• Facility Monitoring
  • 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.
• Facility Compliance
  • 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.
• State Compliance
  • 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.
• Staff Compliance
  • 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.

Qualifications

• PharmD or Bachelor of Pharmacy
• Minimum of 5 years of experience as a pharmacist in a regulatory, compliance, or compounding environment
• Valid pharmacist license within the state of Texas
• Strong understanding of healthcare regulations and sterile compounding best practices
• Sterile Compounding IV certification or willing to get certified within 90 days of employment
• 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

Preferred Qualifications

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

Physical Requirements

• Ability to sit for extended periods of time at a desk and working on a computer
• Ability to communicate effectively in person, over the phone, or via virtual meeting
• Ability to maintain focus in a typical office environment with moderate noise levels
• Ability to perform repetitive motions with hands and arms, such as typing.

Benefits

• Comprehensive benefits package including medical, dental, 401K retirement plan and paid time off.