Regulatory Affairs Pharmacist

Company Overview

Southend Pharmacy is a leading 503A compounding pharmacy dedicated to deliveringhigh-quality patient-specific medications with a focus on clinical excellence operationalefficiency and compassionate care. As part of Allia Health Group we operate with integrity andinnovation setting the standard for personalized pharmaceutical services.

Job Summary

Southend Pharmacy is seeking a dedicated and detail-orientedRegulatory 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 inspectionsand other accreditation agency reviews.

Identify and document compliance risks or deviations preparing thoroughdiscrepancy and incident reports.

Ensure documentation consistently meets requirements for audits and regulatoryreview.

Facility Compliance

Ensure adherence to federal and state pharmacy laws and regulations (FDADEA HIPAA state boards of pharmacy).

Monitor and maintain compliance with USP <795> <797> and <800> standardsfor compounding per assigned state guidelines.

Assist in developing reviewing and updating Standard Operating Procedures(SOPs).

Stay current on evolving pharmacy laws and regulations in assignedstates providing timelyupdates and education to staff.

Collaborate with management on incident reporting root cause analysis andcorrective action plans.

State Compliance

Attend all state board of pharmacy meetings for assigned states to stay up todate 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 rulesand regulations that govern those states.

Staff Compliance

Maintain accurate and up-to-date licensure records for pharmacists inassigned states.

Ensure compliance-related acknowledgments and training are tracked anddocumented for pharmacists in your assigned states.

Serve as a trusted point of contact for compliance-related questions orconcerns.

What we Require

PharmD or Bachelor of Pharmacy

Minimum of 5 years of experience as a pharmacistin a regulatorycompliance or compounding environment

• Strong understanding of healthcare regulations and sterile compounding bestpractices

Demonstrated experience monitoring and maintaining compliance with USP<795> <797> and <800>.

Strong knowledge of federal and state pharmacy laws and guidelines (FDADEA HIPAA TSBP)

Proven ability to identify compliance risks or deviations and recommendcorrective 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 pharmacysetting

Hands-on experience developing reviewing and updating SOPs for complianceand 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.

Southend Pharmacy isunable 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

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.