DEA Compliance Specialist, Regulatory Affairs

Gifthealth•Columbus, OH

12d

About The Position

Gifthealth is seeking a DEA Compliance Specialist in Regulatory Affairs to serve as the day-to-day subject matter expert on DEA requirements. The role ensures prescribers are properly credentialed and authorized to prescribe controlled substances and helps the specialty direct-to-patient pharmacy remain current with changing federal and state controlled substance regulations. It supports the Compliance department and partners with Pharmacy Operations, Client Success, and Quality. The position reports to the Director of Compliance. The specialist verifies prescriber credentials, monitors regulatory developments, translates changes into operational guidance, maintains compliance procedures, supports training and corrective actions, and assists with audits, inspections, registration activities, and regulatory or partner inquiries. The role also prepares metrics and reporting related to prescriber verification.

Requirements

Bachelor's degree in healthcare administration, pharmacy, public policy, or a related field preferred, or equivalent experience.
Three to five years of experience in pharmacy, healthcare, or life sciences compliance, with direct experience in DEA or controlled substance regulations.
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 audiences outside compliance.
Sound judgment, discretion, and comfort working independently.
Ability to remain stationary for extended periods while writing or reviewing documentation.
Ability to work on a computer for the entire shift.
Ability to attend virtual meetings with cross-functional teams.

Nice To Haves

CPhT, RPh, or compliance certification such as CHC.
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.

Responsibilities

Review and verify prescriber credentials during onboarding, including DEA registration status, state licensure, NPI, and state-specific controlled substance registrations.
Confirm that prescribers' DEA registrations are valid for the state and medication schedules involved.
Identify and resolve discrepancies, expirations, and red flags, escalating high-risk findings to the Director of Compliance.
Maintain accurate, audit-ready prescriber files and documentation.
Conduct periodic re-verification and monitor credentials for expirations, sanctions, and exclusions.
Track federal DEA regulatory changes and guidance, including the Controlled Substances Act, Ryan Haight Act, telemedicine prescribing flexibilities, and related rulemaking.
Monitor state-level developments from pharmacy boards, medical boards, and controlled substance authorities.
Translate regulatory changes into operational guidance and recommend updates to policies, procedures, and workflows.
Maintain a regulatory change log and brief leadership on relevant upcoming or active changes.
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 related to DEA or prescriber compliance gaps.
Support DEA, state board, accreditation, payer, and manufacturer partner audits and inspections.
Prepare compliance metrics and reports on prescriber verification volumes, exceptions, and trends.
Support DEA registration transfers, renewals, and multi-site considerations.
Assist with responses to inquiries from regulators, partners, and clients.