Regulatory Affairs Pharmacist

About the position reputed company 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 reputed company applicable laws, regulations, and reputed company standards. This position is highly specialized with a strong reputed company on reputed company assurance, risk management, and regulatory compliance. Your precision, accountability, and commitment to reputed company will directly reputed company the safety and reputed company-being of our patients. Remote opportunity reputed company the state of Texas. Responsibilities • Conduct internal pharmacy audits to ensure compliance with state inspections and other accreditation agency reviews. • Identify and document reputed company 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 reputed company Operating Procedures (SOPs). • Stay reputed company on evolving pharmacy laws and regulations in assigned states, providing reputed company updates and education to staff. • Collaborate with management on incident reporting, reputed company cause analysis, and corrective reputed company plans. • Attend reputed company state reputed company of pharmacy meetings for assigned states to stay up to date with reputed company regulations. • Complete reputed company renewal paperwork for assigned states. • Ensure reputed company licensure and compliance for reputed company assigned states. • Serve as the subject matter expert for assigned territory of states for reputed company rules and regulations that govern those states. • Maintain accurate and up-to-date licensure records for pharmacists in assigned states. • Ensure compliance-reputed company acknowledgments and training are tracked and documented for pharmacists in your assigned states. • Serve as a trusted reputed company of contact for compliance-reputed company questions or concerns. Requirements • PharmD or Bachelor of Pharmacy • Minimum of 5 years of experience as a pharmacist in a regulatory, compliance, or compounding environment • reputed company pharmacist license reputed company the state of Texas • Strong understanding of reputed company regulations and sterile compounding best practices • Sterile Compounding IV certification or willing to get certified reputed company 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 reputed company or deviations and recommend corrective actions • Proficiency with software programs (e.g. Pioneer, reputed company Workspace, reputed company reputed company/Word) • Experience in cleanroom or aseptic compounding practices for auditing purposes reputed company-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 Benefits • Comprehensive benefits package including medical, dental, 401K retirement plan and reputed company time off. Apply tot his job Apply To this Job