Senior 340B Regulatory Advisor - Remote

VytlOne; United States; Remote; USD 100,000 - 115,000; Full time

Benefits offered by this job

Health benefits

401k

PTO

Earned Wage Access

Job summary

VytlOne is seeking a Regulatory Affairs Manager, 340B Programs, to provide regulatory research, interpretation, and advisory support to operations and the 340B Program Services team. The role monitors the regulatory landscape, translates complex requirements into practical guidance for internal teams and clients, and supports audits, policy documentation, and staff training.

This is a remote, home-based position requiring a HIPAA-compliant setup and the ability to work independently across

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 preferred but not required.
• Minimum 3–5 years of experience in 340B program compliance or related regulatory field.
• Experience supporting HRSA audits, manufacturer audits, or internal compliance reviews preferred.
• Experience conducting healthcare regulatory research and translating findings into operational guidance preferred.
• Remote work experience preferred.
• Strong working knowledge of the 340B Drug Pricing Program and related HRSA requirements.
• Familiarity with Medicaid and Medicare billing implications and 340B compliance considerations.
• Knowledge of contract pharmacy arrangements and related regulatory considerations.
• Familiarity with state-level pharmacy law variances is a plus.
• Understanding of HIPAA privacy and security requirements.

Responsibilities

• Monitor and research federal and state regulations and HRSA guidance affecting 340B compliance.
• Translate regulatory changes into clear, practical guidance for internal teams and clients.
• Support HRSA and manufacturer audits and internal self-audits with documentation and response prep.
• Develop and update policy documentation, job aids, and reference materials.
• Partner with Compliance, Legal, Pharmacy Services & Operations to assess regulatory risk.
• Deliver regulatory guidance and training on 340B eligibility rules and program integrity.

Skills

Regulatory research

HRSA guidance

340B program

Policy interpretation

Client-facing

Education

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

MPH or MHA preferred

Apexus 340B ACE/ADR preferred

Job description

VytlOne is seeking a Regulatory Affairs Manager, 340B Programs, to provide regulatory research, interpretation, and advisory support to operations and the 340B Program Services team. The role monitors the regulatory landscape, translates complex requirements into practical guidance for internal teams and clients, and supports audits, policy documentation, and staff training.

This is a remote, home-based position requiring a HIPAA-compliant setup and the ability to work independently across