Remote 340B Regulatory Advisor - Policy & Compliance

Maxor National Pharmacy Services, LLC in; Amarillo (TX); On-site; USD 100,000 - 115,000; Full time

Benefits offered by this job

Medical/dental/vision benefits

401k with match

Paid time off

Job summary

VytlOne seeks a Regulatory Advisor to provide regulatory research, interpretation, and advisory support for the 340B Program Services. This remote, home-based role supports audit readiness, policy documentation, and client guidance across federal and state requirements.

You will translate complex regulatory changes into practical operational guidance, train staff and clients, and collaborate across Compliance, Legal, Pharmacy Services, and Operations.

Qualifications

• Bachelor's degree in health policy, public health, healthcare administration, or a related field.
• Advanced degree (e.g., MPH, MHA) or relevant professional certification (e.g., Apexus 340B ACE or ADR) preferred but not required.
• Minimum 3-5 years of experience in 340B program compliance, healthcare regulatory affairs, pharmacy compliance, or a related regulatory field.
• Experience supporting HRSA audits, manufacturer audits, or internal compliance reviews strongly preferred.
• Experience conducting healthcare regulatory research and translating findings into operational or policy guidance preferred.
• Prior remote work experience demonstrating self-direction and reliable, independent performance preferred.
• Strong working knowledge of the 340B Drug Pricing Program, including Section 340B of the Public Health Service Act and HRSA program requirements.

Responsibilities

• Monitor and research federal and state regulations, HRSA guidance, policy releases, OPAIS updates, and manufacturer restrictions affecting 340B Program compliance.
• Translate regulatory and policy changes into clear, practical operational guidance for internal teams and covered entity clients.
• Support HRSA audits, manufacturer audits, and internal self-audits by researching applicable requirements, reviewing documentation, and assisting with response preparation.
• Develop, maintain, and update internal policy and procedure documentation, job aids, and reference materials reflecting current 340B regulatory requirements.
• Partner with Compliance, Legal, Pharmacy Services & Operations, and Program Operations to assess regulatory risk on program changes, new client onboarding, and contract pharmacy arrangements, escalating novel or high-risk questions for formal legal/compliance determination.
• Deliver regulatory guidance, education, and training sessions to internal staff and clients on 340B eligibility rules, prohibited practices (e.g., duplicate discounts, diversion), and program integrity requirements.
• Track, summarize, and communicate federal and state legislative and regulatory developments that may affect the 340B program and covered entity operations.
• Support due diligence activities for new covered entity onboarding, contract pharmacy set-up, and eligibility determinations by researching and documenting relevant regulatory requirements.
• Respond to internal inquiries on regulatory questions within scope of the role, and appropriately elevate matters requiring formal legal interpretation or compliance sign-off to Legal or Compliance.
• Maintain awareness of industry guidance and best practices through engagement with organizations such as Apexus and 340B Health.
• Document regulatory research, findings, and advisory recommendations in accordance with company recordkeeping and HIPAA data handling policies.
• Promote and ensure compliance with VytlOne Business Code of Conduct, as well as other company policies and procedures.
• Promptly report any allegations of impropriety to the Compliance Department.
• Comply with VytlOne's Ethical Business Conduct policy and VytlOne's Compliance Program.
• Remain free from exclusion under the OIG and SAMS Medicare/Medicaid lists.
• Complete required training, as assigned, within the established timeframes.
• Must be able to cope with the mental and emotional stress of the position.
• Maintain regular attendance in accordance with established policies.
• Perform other job-related duties as assigned.

Skills

Regulatory research

340B program expertise

Regulatory guidance

Audit readiness

Policy interpretation

Education

Bachelor's degree in health policy/public health/healthcare administration

MPH or MHA preferred

Tools

Regulatory databases

Policy tracking software

Job description

VytlOne seeks a Regulatory Advisor to provide regulatory research, interpretation, and advisory support for the 340B Program Services. This remote, home-based role supports audit readiness, policy documentation, and client guidance across federal and state requirements.

You will translate complex regulatory changes into practical operational guidance, train staff and clients, and collaborate across Compliance, Legal, Pharmacy Services, and Operations.