Vice President, Regulatory Affairs

Company Overview

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.

Position Summary

The Vice President, Regulatory Affairs is responsible for leading all regulatory strategies, submissions, and compliance efforts, ensuring that Empower meets Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), state boards of pharmacy, and global regulatory requirements while expanding access to life-changing medications.

This leader will develop and execute a proactive, artificial intelligence (AI)-powered regulatory strategy, integrating real-time compliance tracking, regulatory intelligence, and automation to streamline approvals, mitigate risk, and optimize market entry. From product submissions and labeling compliance to regulatory risk management and policy advocacy, this role ensures Empower remains at the forefront of pharmaceutical and healthcare compliance.

If you are a seasoned regulatory affairs executive with expertise in AI-driven regulatory intelligence, global compliance strategy, and regulatory operations automation, this is your opportunity to lead the next evolution of regulatory excellence at Empower.

Duties And Responsibilities

• Develop and execute a best-in-class regulatory affairs strategy, ensuring global compliance, accelerated approvals, and strategic regulatory alignment.
• Leverage AI-powered regulatory intelligence and predictive analytics to optimize regulatory submissions, compliance tracking, and approval timelines.
• Oversee all interactions with FDA, DEA, state boards of pharmacy, global regulatory agencies, National Association of Boards of Pharmacy (NABP), Pharmacy Compounding Accreditation Board (PCAB), and telemedicine certification organizations, ensuring seamless engagement and successful approval pathways.
• Ensure compliance with current Good Manufacturing Practices, United States Pharmacopeia, and global regulatory frameworks, integrating automated compliance monitoring systems.
• Optimize regulatory submissions, Investigational New Drug applications, New Drug Application filings, and post-market compliance, ensuring faster approvals and market access.
• Deploy AI-enhanced risk assessment models, ensuring real-time regulatory risk identification, mitigation, and reporting.
• Lead global labeling compliance, adverse event reporting, and post-market surveillance, ensuring products meet regulatory expectations and public safety standards.
• Develop and oversee regulatory policy advocacy, ensuring Empower remains a key voice in shaping industry regulations and healthcare policies.
• Enhance regulatory digital transformation, deploying automated regulatory document management and AI-driven submission tracking.
• Build and lead a high-performance regulatory affairs team, fostering a culture of compliance excellence, innovation, and strategic execution.
• Serve as a trusted regulatory advisor to the executive leadership team, ensuring regulatory strategy aligns with corporate growth, new product development, and international expansion.

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.

Knowledge And Skills

Key Competencies

Values

Experience And Qualifications

Employee Benefits, Health, And Wellness

Additional Voluntary Benefits

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