Regulatory Advisor, 340B Program Services

Overview

The Regulatory Affairs Manager, 340B Programs, provides regulatory research, interpretation, and advisory support to operations and the 340B Program Services team across pharmacy pricing and healthcare regulatory matters, including the 340B Drug Pricing Program, HRSA guidance, federal and state pharmacy law, manufacturer restrictions and rebate models, drug pricing and reimbursement developments, and related regulatory requirements. This role monitors the regulatory landscape, translates complex regulatory requirements into practical operational guidance for internal teams and covered entity clients, and supports audit readiness, policy documentation, and staff training.

The Regulatory Advisor acts as an internal subject matter resource and advisory partner; final legal opinions, contract language, and formal compliance determinations remain the responsibility of the Legal and Compliance departments. This is a remote, home-based position requiring a reliable, HIPAA-compliant home office setup and the ability to work independently across multiple teams and client engagements.

Salary Range: $100,000 to $115,000.

Did you know that patients see their pharmacist an average of 12 times a year? Pharmacy is at the heart of healthcare. Come join Vytl One and make a direct impact on patients’ lives. Improve your own wellbeing with our robust benefits and flexible work environment. At Vytl One, you have a career with limitless possibilities and the charge to make a difference.

A company of 1,000 diverse people and almost 100 years of pharmacy experience, we offer the stability of a Fortune 500 company with the energy and innovation of a startup. We provide services and technology that fuel the entire pharmacy ecosystem, but we are more than pharmacy services. We
enable
pharmacy care.

• 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…