Company Overview
Southend Pharmacy is a modern 503A compounding pharmacy built on clinical precision operational clarity and a human-first approach. Licensed in 20 states and focused on longevity-aligned therapeutics we support providers and their patients with precision in compounding and transparent processes. Southend Pharmacy operates at the intersection of innovation ambition and clinical excellenceblending precision clarity and compassionate support to help providers deliver patient-centered clinically guided care across every step of the treatment journey.
Job Summary
TheRegulatory Affairs Pharmacistwill be responsible for but not limited to ensuring that pharmacy operations remain compliant with all applicable laws regulations and professional standards for an assigned regional territory. This role is the primary Subject Matter Expert (SME) for state-specific licensure renewals and board requirements acting with a high degree of autonomy to safeguard the companys ability to operate legally and safely across multiple jurisdictions.
Key Responsibilities
State Board Management:Serve as the primary point of contact for an assigned region; attend all state board meetings report on regulatory changes and manage all pharmacy and controlled substance licensing renewals.
Compliance Oversight:Monitor and ensure strict adherence to federal and state pharmacy laws (FDA DEA HIPAA) andUSP <795> <797> and <800>standards for all assigned states.
Facility Monitoring:Conduct internal audits to identify compliance risks or deviations; prepare detailed reports and collaborate with management on root cause analysis and corrective action plans.
SOP & Documentation:Assist in the development review and updating of Standard Operating Procedures (SOPs) to ensure documentation consistently meets requirements for audits and regulatory reviews.
Staff Compliance:Maintain accurate up-to-date licensure records and track compliance-related training acknowledgments for pharmacists within assigned regions.
Independent Research:Conduct deep-dive research into state-specific laws and provide thorough accurate explanations to the compliance team to ensure ongoing operational compliance.
Qualifications
Bachelor of Science in Pharmacy or PharmD.
Must hold an active and unencumbered Pharmacist license.
At least 5 years of experience as a Pharmacist with a focus on compliance regulatory affairs or cleanroom compounding.
Strong understanding of healthcare regulations and sterile compounding best practices (USP <797> and <800>)
Proficiency with Google Workspace (Sheets Docs) or Microsoft Office Suite (Excel Word).
Exceptional accuracy organization and diligent communication skills.
Preferred
Recent experience working in or managing compliance for a cleanroom environment.
Experience in a 503A or 503B specialty pharmacy setting.
Familiarity with pharmacy audit software quality tracking platforms or compliance monitoring tools.
Residency in the assigned region (East Coast or West Coast) is a plus.
Physical Requirements
Ability to maintain a dedicated and secure home office environment suitable for handling sensitive regulatory data.
Ability to sit for extended periods of time while working on a computer and attending virtual meetings.
Ability to communicate effectively via phone email and video conferencing platforms.
Ability to perform repetitive motions with hands and arms such as typing.
Benefits
Salary Range:$110000 - $130000 annually.
Work Arrangement: Remote - US based.
Comprehensive benefits package including medical dental paid time off.
401(k) retirement savings plan.
Eligible for quarterly bonus based on performance and departmental goals.
Ample opportunities for professional development and career growth.
Southend Pharmacyis 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.
Full-time Monday through Friday 7:00 AM 4:00 PM.
Required Experience:
IC
Company OverviewSouthend Pharmacy is a modern 503A compounding pharmacy built on clinical precision operational clarity and a human-first approach. Licensed in 20 states and focused on longevity-aligned therapeutics we support providers and their patients with precision in compounding and transparen...
Company Overview
Southend Pharmacy is a modern 503A compounding pharmacy built on clinical precision operational clarity and a human-first approach. Licensed in 20 states and focused on longevity-aligned therapeutics we support providers and their patients with precision in compounding and transparent processes. Southend Pharmacy operates at the intersection of innovation ambition and clinical excellenceblending precision clarity and compassionate support to help providers deliver patient-centered clinically guided care across every step of the treatment journey.
Job Summary
TheRegulatory Affairs Pharmacistwill be responsible for but not limited to ensuring that pharmacy operations remain compliant with all applicable laws regulations and professional standards for an assigned regional territory. This role is the primary Subject Matter Expert (SME) for state-specific licensure renewals and board requirements acting with a high degree of autonomy to safeguard the companys ability to operate legally and safely across multiple jurisdictions.
Key Responsibilities
State Board Management:Serve as the primary point of contact for an assigned region; attend all state board meetings report on regulatory changes and manage all pharmacy and controlled substance licensing renewals.
Compliance Oversight:Monitor and ensure strict adherence to federal and state pharmacy laws (FDA DEA HIPAA) andUSP <795> <797> and <800>standards for all assigned states.
Facility Monitoring:Conduct internal audits to identify compliance risks or deviations; prepare detailed reports and collaborate with management on root cause analysis and corrective action plans.
SOP & Documentation:Assist in the development review and updating of Standard Operating Procedures (SOPs) to ensure documentation consistently meets requirements for audits and regulatory reviews.
Staff Compliance:Maintain accurate up-to-date licensure records and track compliance-related training acknowledgments for pharmacists within assigned regions.
Independent Research:Conduct deep-dive research into state-specific laws and provide thorough accurate explanations to the compliance team to ensure ongoing operational compliance.
Qualifications
Bachelor of Science in Pharmacy or PharmD.
Must hold an active and unencumbered Pharmacist license.
At least 5 years of experience as a Pharmacist with a focus on compliance regulatory affairs or cleanroom compounding.
Strong understanding of healthcare regulations and sterile compounding best practices (USP <797> and <800>)
Proficiency with Google Workspace (Sheets Docs) or Microsoft Office Suite (Excel Word).
Exceptional accuracy organization and diligent communication skills.
Preferred
Recent experience working in or managing compliance for a cleanroom environment.
Experience in a 503A or 503B specialty pharmacy setting.
Familiarity with pharmacy audit software quality tracking platforms or compliance monitoring tools.
Residency in the assigned region (East Coast or West Coast) is a plus.
Physical Requirements
Ability to maintain a dedicated and secure home office environment suitable for handling sensitive regulatory data.
Ability to sit for extended periods of time while working on a computer and attending virtual meetings.
Ability to communicate effectively via phone email and video conferencing platforms.
Ability to perform repetitive motions with hands and arms such as typing.
Benefits
Salary Range:$110000 - $130000 annually.
Work Arrangement: Remote - US based.
Comprehensive benefits package including medical dental paid time off.
401(k) retirement savings plan.
Eligible for quarterly bonus based on performance and departmental goals.
Ample opportunities for professional development and career growth.
Southend Pharmacyis 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.
Full-time Monday through Friday 7:00 AM 4:00 PM.
Required Experience:
IC
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