Strategic 340B Regulatory Advisor (Remote)

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

Benefits offered by this job

Health insurance

401k plan

Paid time off

Earned Wage Access

Flexible work environment

Job summary

VytlOne is seeking a Regulatory Affairs Manager for 340B Programs to provide regulatory research, interpretation, and advisory support across the 340B landscape, HRSA guidance, and related healthcare regulations. This remote, home-based role requires delivering practical guidance to operations and clients while maintaining HIPAA compliance.

You will monitor regulatory changes, support audits, develop policy documents, train staff, and collaborate with Compliance, Legal, Pharmacy Services, and

Qualifications

• Bachelor's degree in health policy or related field is required.
• Advanced degree or APexus 340B ACE/ADR preferred but not required.
• Minimum 3–5 years in 340B program compliance or healthcare regulatory affairs.
• Experience supporting HRSA audits and internal compliance reviews is preferred.
• Strong ability to translate regulatory language into actionable guidance.

Responsibilities

• Monitor and research federal/state regulations, HRSA guidance, and 340B compliance requirements.
• Translate regulatory changes into practical operational guidance for teams and clients.
• Support HRSA and manufacturer audits and internal self-audits.
• Develop and update internal policy documentation and training materials.
• Collaborate with Compliance, Legal, Pharmacy Services & Operations to assess regulatory risk.
• Deliver regulatory guidance and training on 340B eligibility rules and compliance.
• Summarize regulatory developments affecting the 340B program.
• Assist due diligence for new client onboarding and contract pharmacy setup.
• Escalate matters requiring formal legal interpretation to Legal/Compliance.

Skills

Regulatory research

Regulatory interpretation

Regulatory advisory

340B knowledge

Audits support

HIPAA compliance

Policy documentation

Staff training

Cross-functional collaboration

Project management

Education

Bachelor's degree in health policy, public health, healthcare administration, or related field

Advanced degree (MPH, MHA) or Apexus 340B ACE/ADR preferred

Tools

Apexus 340B ACE

Job description

VytlOne is seeking a Regulatory Affairs Manager for 340B Programs to provide regulatory research, interpretation, and advisory support across the 340B landscape, HRSA guidance, and related healthcare regulations. This remote, home-based role requires delivering practical guidance to operations and clients while maintaining HIPAA compliance.

You will monitor regulatory changes, support audits, develop policy documents, train staff, and collaborate with Compliance, Legal, Pharmacy Services, and