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 - 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 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. Equal Opportunity Employer Statement Southend Pharmacy 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.

• Provide support to clients of Compliance Services. • Develop contracts for HCPs using templates. • Communicate with HCPs regarding contracts, obtain signatures, answer questions. • Ensure good quality work deliveries complying with various policies. • Reformat incoming files using Access, Excel, etc. • Review client requirements to ensure clarity on requests.

• Provide GCP compliance support to clinical study teams under the direction of the Sr. Manager or the Associate Director • Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas • Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed • Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities • Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches • Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies • Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues • Participate in vendor evaluations as a Subject Matter Expert (SME) as needed • Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings • Provide support and guidance for Quality Management System activities including self-reporting deviations, root cause analysis, and CAPA plan development and evaluation • Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion • Lead/manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections

• Provide quality leadership and direction to sponsor R&D stakeholders on GCP-related activities/issues and act as GCP expert/consultant for R&D colleagues. • Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas. • Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed. • Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness). • Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches. • Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies. • Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues. • Participate in vendor evaluations as a Subject Matter Expert (SME) as needed. • Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings. • Provide support and guidance for sponsor Quality Management System activities including self-reporting deviations, root cause analysis, and CAPA plan development and evaluation. • Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion. • Maintain a high level of expertise in international GCP regulations and internal Policies and Procedures that may impact drug development. • Provide support and guidance during and following internal audits and external regulatory inspections (as required). • Provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities. • Lead / manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections.