DEA Compliance Specialist - Regulatory Affairs

Description

Position Summary

We are seeking a DEA Compliance Specialist, Regulatory Affairs to ensure every prescriber we work with is properly credentialed and authorized to prescribe controlled substances, and that Gifthealth, a specialty direct-to-patient pharmacy serving patients across multiple states, stays ahead of changing federal and state controlled substance regulations. This role is the organization's day-to-day subject matter expert on DEA requirements.

This position plays a key role in supporting the Compliance department and is a key partner to Pharmacy Operations, Client Success, and Quality. The DEA Compliance Specialist will report to the Director of Compliance, ensuring alignment with organizational goals, operational excellence, and compliance standards.

Key Responsibilities

• Review and verify prescriber credentials during onboarding, including DEA registration status, state licensure, NPI, and state-specific controlled substance registrations.
• Confirm that each prescriber's DEA registration is valid for the state in which they are prescribing and for the schedules of medication prescribed.
• Identify and resolve discrepancies, expirations, and red flags, and escalate high-risk findings to the Director of Compliance.
• Maintain accurate, audit-ready prescriber files and documentation.
• Conduct periodic re-verification of prescriber credentials and monitor for expirations, sanctions, and exclusions.
• Track changes to DEA regulations and guidance, including the Controlled Substances Act, Ryan Haight Act, telemedicine prescribing flexibilities, and related rulemaking.
• Monitor state-level developments from state boards of pharmacy, medical boards, and state controlled substance authorities.
• Translate regulatory changes into clear operational guidance, and recommend updates to policies, procedures, and workflows.
• Maintain a regulatory change log and brief leadership on upcoming or active changes that affect the business.
• Draft, update, and maintain SOPs related to DEA compliance, prescriber verification, and controlled substance handling.
• Train pharmacy, intake, and client success teams on prescriber validation requirements and escalation paths.
• Partner with Pharmacy Operations and Quality on corrective and preventive actions (CAPAs) tied to DEA or prescriber compliance gaps.
• Support DEA, state board, accreditation, payer, and manufacturer partner audits and inspections.
• Prepare compliance metrics and reporting on prescriber verification volumes, exceptions, and trends.
• Support DEA registration activities, including registration transfers, renewals, and multi-site considerations.
• Assist with responses to inquiries from regulators, partners, and clients.

Requirements

Qualifications

Education: Bachelor's degree in healthcare administration, pharmacy, public policy, or a related field preferred (or equivalent experience).

Licensure/Certification: CPhT, RPh, or compliance certification (such as CHC) is a plus.

Experience: 3 to 5 years of experience in pharmacy, healthcare, or life sciences compliance, with direct experience in DEA or controlled substance regulations.

Skills:

• Working knowledge of DEA registration requirements, prescriber validation, and the Controlled Substances Act.
• Familiarity with state pharmacy and medical board requirements across multiple states.
• Strong research, analytical, and documentation skills, with high attention to detail.
• Ability to interpret regulations and explain them clearly to non-compliance audiences.
• Sound judgment, discretion, and comfort working independently.

Desired Attributes

• Experience in specialty, mail-order, or telehealth-connected pharmacy environments.
• Experience with URAC, NABP, or similar accreditation standards.
• Familiarity with PBM and manufacturer program requirements.
• Regulatory expertise and curiosity.
• Accuracy and follow-through.
• Clear written and verbal communication.
• Cross-functional collaboration.
• Risk awareness and ethical judgment.
• Ability to manage competing priorities in a fast-moving environment.

Work Environment

Location: Columbus, OH (or hybrid/remote, depending on business need).

Schedule: Full-time.

• Regular meetings with the Director of Compliance, Pharmacy Operations, Client Success, and Quality to ensure alignment.

Key Essential Functions

• Must be able to remain in a stationary position for extended periods while writing or reviewing documentation.
• Must be able to work on a computer for the entire shift.
• Must be able to attend virtual meetings with cross-functional teams.

Equal Employment Opportunity (EEO) Statement

Gifthealth is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, national origin, age, disability, veteran status, or any other legally protected status.

Disclaimer

This job description is intended to describe the general nature and level of work being performed. It is not intended to be an exhaustive list of all responsibilities, duties, or skills required of personnel. Gifthealth reserves the right to modify job duties or descriptions at any time.