Regulatory Compliance Specialist

Akina Pharmacy • Sterling, VA

10d

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.

Requirements

• Education: Bachelor’s Degree in Pharmacy, Regulatory Affairs, Life Sciences, Healthcare Administration, or a related field preferred.
• Expertise: 2-3+ years of direct compliance or regulatory experience within a 503A and/or 503B pharmacy environment required.
• Regulatory Familiarity: Working knowledge of cGMP, USP <797>, <795>, and <800>. Experience in pharmaceutical compounding operations or regulated environments is preferred.
• Technology Skills: Proficient in digital quality management systems, data tracking tools, and SOP documentation platforms. Comfortable navigating and adapting to evolving technology systems.
• Soft Skills: 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.

Responsibilities

• Regulatory Intelligence & Interpretation
• Licensure, Registration & Credential Oversight
• Audit, Inspection & Regulatory Readiness
• Compliance Systems, Controls & Documentation
• Training, Communication & Cross-Functional Partnership

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