Regulatory Compliance Specialist

Akina Pharmacy • Sterling, VA

9d

About The Position

The Regulatory Compliance Specialist serves as Akina Pharmacy’s regulatory subject matter expert, responsible for ensuring sustained compliance across all pharmacy operations. This role provides hands-on ownership of regulatory monitoring, licensure management, audit readiness, and implementation of compliance controls aligned with USP standards, state Boards of Pharmacy, DEA requirements, and FDA guidance. This position is proactive and execution-focused, requiring an individual who has actively operated in a pharmacy compliance role and can independently translate complex regulations into practical, defensible systems. The Compliance Specialist partners closely with Quality, Regulatory Compliance, Operations, and Leadership to ensure Akina remains continuously inspection-ready. Success in this role is rooted in Akina’s values— Excellence Always, Go-Getter’s Unite, Compassion For All, and Called To Serve —and will be evident in your commitment to compliance, training, data integrity, and collaboration. You will love it here if you are motivated by Akina’s Core Identity Values: Excellence Always Go-Getter’s Unite Compassion For All Called To Serve You’ll have success here if you value clear processes and get, want, and have capacity to do the following things:

Requirements

• Bachelor’s Degree in Pharmacy, Regulatory Affairs, Life Sciences, Healthcare Administration, or a related field preferred.
• 2-3+ years of direct compliance or regulatory experience within a 503A and/or 503B pharmacy environment required.
• Working knowledge of cGMP, USP <797>, <795>, and <800>.
• Proficient in digital quality management systems, data tracking tools, and SOP documentation platforms.
• Comfortable navigating and adapting to evolving technology systems.
• Strong regulatory interpretation skills, audit leadership, SOP development, and the ability to implement durable compliance systems.
• Excellent written and verbal communication skills with exceptional organization and attention to detail.

Nice To Haves

• Experience in pharmaceutical compounding operations or regulated environments is preferred.

Responsibilities

• Maintain knowledge of USP <795>, <797>, and <800>, state Board of Pharmacy regulations, DEA requirements, and FDA guidance applicable to 503A compounding pharmacies.
• Actively monitor regulatory changes, enforcement trends, and inspection findings.
• Perform documented impact assessments to determine applicability, risk level, and required operational changes.
• Translate regulatory requirements into clear guidance, SOP updates, and implementation plans.
• Manage day-to-day administration of professional and facility licensure, including pharmacists, technicians, interns, non-resident pharmacy licenses, controlled substance registrations, and other regulatory permits.
• Maintain structured tracking systems to ensure timely renewals, accurate submissions, and state-specific compliance requirements.
• Conduct periodic internal reviews of licensure documentation to identify and correct deficiencies before external inspection exposure.
• Execute a risk-based internal compliance audit program focused on regulatory, licensure, and documentation controls.
• Coordinate inspection readiness activities, including mock inspections, documentation reviews, and preparation of regulatory binders.
• Serve as a key compliance representative during Board of Pharmacy inspections and regulatory inquiries.
• Support response drafting, corrective action tracking, and remediation efforts in partnership with Quality and Regulatory Compliance leadership.
• Maintain sustainable compliance systems designed to prevent regulatory drift.
• Draft, review, and revise SOPs, policies, forms, and compliance tools to ensure alignment with current regulations and inspection expectations.
• Implement monitoring mechanisms, checklists, and periodic reviews to verify ongoing adherence and effectiveness of controls.
• Provide structured regulatory training to pharmacy staff, leadership, and cross-functional teams.
• Communicate regulatory expectations in clear, practical terms that drive compliance without disrupting operations.
• Act as a trusted compliance advisor to Quality, Operations, and Clinical teams by embedding regulatory considerations into process changes, new initiatives, and continuous improvement efforts.

Benefits

• Comprehensive Medical, Dental, and Vision Options: Choose from thwo medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
• Paid time off (vacation and sick time) : Take advantage of generous paid time off to recharge, focus on personal priorities, and maintain a healthy work-life balance.
• Paid Holidays (6 scheduled): Enjoy eight scheduled paid holidays to celebrate and spend quality time with loved ones.
• 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a Safe-Harbor match up to 4%.
• Rewards & Recognition Program: Be celebrated for your hard work and achievements through our dedicated rewards and recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level