Southend Pharmacy is a leading 503A compounding pharmacy dedicated to delivering high-quality, patient-specific medications with a focus on clinical excellence, operational efficiency, and compassionate care. As part of Allia Health Group , we operate with integrity and innovation, setting the standard for personalized pharmaceutical services.
Job Summary
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, and
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 staffCollaborate with management on incident reporting, root cause analysis, and corrective action plansState Compliance
Attend all state board of pharmacy meetings for assigned states to stay up to date with current regulationsComplete all renewal paperwork for assigned statesEnsure proper licensure and compliance for all assigned statesServe as the subject matter expert for assigned territory of states for all rules and regulations that govern those statesStaff Compliance
Maintain accurate and up-to-date licensure records for pharmacists in assigned statesEnsure compliance-related acknowledgments and training are tracked and documented for pharmacists in your assigned statesServe as a trusted point of contact for compliance-related questions or concernsRequired Qualifications
PharmD or Bachelors of PharmacyMinimum of 5 years of experience as a Pharmacistin a regulatory, compliance, or compounding environment.Valid pharmacist license within the state of TexasStrong understanding of healthcare regulations and sterile compounding best practicesSterile Compounding IV certification or willing to get certified within 90 days of employmentDemonstrated experience monitoring and maintaining compliance with USP, and
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 actionsProficiency with software programs(e.g. Pioneer, Google Workspace, Microsoft Excel / Word)Experience in cleanroom or aseptic compounding practices for auditing purposesPreferred Qualifications
Experience supporting compounding in a 503A or 503B specialty pharmacy settingHands-on experience developing, reviewing, and updating SOPs for compliance and compoundingPhysical Requirements
Ability to sit for extended periods of time at a desk and working on a computerAbility to communicate effectively in person, over the phone, or via virtual meetingAbility to maintain focus in a typical office environment with moderate noise levelsAbility to perform repetitive motions with hands and arms, such as typingBenefits
Comprehensive benefits package including medical, dental, paid time offSouthend Pharmacy
is
unable to offer visa sponsorship at this time. Candidates must be legally authorized to work in the United States without current or future sponsorship.
Equal Opportunity Employer Statement
Allia Health Group 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.