Remote 340B Regulatory Advisor | Compliance & Guidance

VytlOne

Northern (KY)

Hybrid

USD 100,000 - 115,000

Full time

14 days+

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Job summary

VytlOne seeks a Regulatory Affairs Manager for 340B Programs to oversee regulatory research, interpretation, and advisory support for operations and the 340B Program Services team. You will translate complex regulatory requirements into practical guidance for internal teams and covered entity clients, while supporting audits and policy documentation.

You will develop training, maintain policy materials, and collaborate with Compliance, Legal, Pharmacy Services, and Program Operations.

Qualifications

Bachelor's degree in health policy, public health, healthcare administration, or a related field required.
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.
Familiarity with Medicaid and Medicare billing implications, 340B compliance (e.g., duplicate discount, diversion, etc.), Inflation Reduction Act (IRA) drug price negotiations, and 340B manufacturer rebate model implications.
Knowledge of contract pharmacy arrangements and related regulatory considerations.
Familiarity with state-level pharmacy law variances affecting 340B operations is a plus.
Understanding of HIPAA privacy and security requirements and safe handling of protected health information (PHI).
Strong research and analytical skills, with the ability to interpret complex regulatory language and identify practical implications.
Ability to translate regulatory and legal concepts into clear, actionable guidance for non-regulatory audiences.
Excellent written and verbal communication skills, with the ability to explain complex regulatory requirements clearly, accurately, and professionally to clients and other non-regulatory audiences; develop client-ready training and reference materials; facilitate meetings; and deliver effective presentations.
Strong project management and organizational skills; able to manage multiple regulatory research initiatives and deadlines concurrently.
Sound judgment in distinguishing advisory guidance from formal legal or compliance determinations, with the discipline to escape the latter to Legal or Compliance.
Ability to work independently and collaboratively in a fully remote, cross-functional environment.
Discretion and sound judgment in handling sensitive and confidential information.
Demonstrated client-facing experience preferred, including building professional relationships with external covered entity stakeholders, assessing client needs, responding to questions, facilitating regulatory discussions, and presenting clear, actionable guidance directly to clients.

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 escalate 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.