Regulatory & Compliance Pharmacist 503B

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.  

What sets us apart is our relentless focus on four core values: People, Quality, Service and Innovation. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.  

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you’ll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let’s revolutionize healthcare, together. Join us and be a part of something extraordinary.  

The Regulatory & Compliance Pharmacist plays a vital role in maintaining Empower’s 503B compliance framework by supporting the Pharmacist-in-Charge (PIC) with the oversight of internal processes, documentation, and regulatory alignment. This role is responsible for monitoring state and federal pharmacy regulations, reviewing promotional and operational materials, coordinating audits, and supporting internal investigations to ensure continuous compliance with the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), United States Pharmacopeia (USP), and State Boards of Pharmacy. By serving as a subject matter expert and quality advocate, the Regulatory & Compliance Pharmacist helps Empower set the standard for operational integrity and regulatory excellence in the compounding pharmacy industry.

• Conducts ongoing reviews of compounded pharmacy products, labeling, and promotional materials to ensure alignment with regulatory standards set by the FDA, DEA, USP, and State Boards of Pharmacy.
• Supports the PIC during internal and external audits, record requests, and regulatory inspections, ensuring timely and accurate documentation and response.
• Authors and maintains Standard Operating Procedures (SOPs), Work Instructions (WIs), and related training materials in collaboration with cross-functional teams; delivers training as needed.
• Conducts internal audits to evaluate compliance with federal and state regulations, good manufacturing practice expectations, and Empower’s internal procedures, documenting findings and supporting corrective action implementation.
• Researches state and federal pharmacy regulations across multiple jurisdictions and provides summarized guidance to inform process improvements and strategic decision-making.
• Assists with the preparation, submission, and tracking of facility license renewals and new license applications; coordinates with consultants and regulatory authorities to ensure compliance.
• Supports deviation and investigation documentation by gathering evidence, participating in root cause analyses, and contributing to timely, thorough, and regulatory-aligned reporting.
• Collaborates with the Legal and Compliance teams to evaluate new or evolving regulations and triage high-priority compliance concerns for escalation and resolution.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

• Strong knowledge of applicable regulatory frameworks including FDA guidance, DEA regulations, USP 795/797/800, and State Board of Pharmacy requirements.
• Demonstrated ability to write and evaluate SOPs and WIs, conduct internal audits, and support deviation investigations with precision and attention to detail.
• Proficient in Microsoft Office tools (Excel, Word, PowerPoint), with excellent communication and critical thinking skills, and the ability to work independently in a fast-paced, compliance-driven environment.

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

• Minimum of 3 to 5 years of relevant experience in a regulatory, compliance, or quality assurance role within a 503B pharmacy, pharmaceutical, or highly regulated healthcare setting.
• Requires a Doctor of Pharmacy (PharmD) or bachelor’s degree in pharmacy.
• Active state pharmacist license in good standing required.

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/