Director of Regulatory Affairs

March 7

🤠 Texas – Remote

Although this job is listed in Texas, this company may be open to hiring remote in other states.

⏰ Full Time

🔴 Lead

🚔 Compliance

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Onnit

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Onnit is an Austin, TX based health and wellness company focused on encouraging peak performance through a combination of unique products and actionable information. With strategy from leading professional athletes and medical practitioners, Onnit has focused on creating naturally derived nutritional supplements and functional foods based upon the latest ingredient science and dietary research. Their flagship nootropic, Alpha BRAIN, is designed to help the body foster optimal brain function with a combination of neuro-specific antioxidants and neurotransmitter precursors. Other formulas for mood, athletic endurance, immune health, and testosterone round out their list of acclaimed formulations. Valuing the importance of the body as well as the mind, Onnit offers functional fitness equipment designed to enhance real world strength and endurance--The final piece on the roadmap to Total Human Optimization.

Nutrition • Fitness • Human Optimization • Health

51 - 200 employees

📋 Description

• About Onnit: • Onnit is an Austin, TX-based supplement company dedicated to supporting everyday heroes—those who need to be fully present and at their best, not only for themselves but also for their families, friends, and colleagues. • As a trusted, serious supplement brand, we provide high-quality products with clinically studied ingredients designed to unlock a deeper mind-body connection and enhance both mental and physical performance. • Unlike other supplement brands, Onnit enables strength from within, empowering individuals to operate at their peak every day. • Backed by medical professionals, industry experts, and a loyal community, we are rapidly growing while staying true to our mission of total human optimization. • Recognized as a Best Place to Work in Austin by the Austin Business Journal, we take pride in fostering a dynamic and purpose-driven environment—and we’d love for you to be part of it. • About the Job: • As the Director of Regulatory Affairs at ONNIT, you will be acting as one of the company’s key experts on regulatory compliance. • You will provide strategic direction, guidance, and insights to relevant stakeholders on both existing and emerging regulations, enforcement initiatives in the regulatory affairs space, product registrations, labeling, and claims to ensure the company's supplements meet industry standards and regulatory requirements. • KEY RESPONSIBILITIES: • Develop and implement regulatory strategies to support the successful launch of new dietary supplements and ensure ongoing product compliance across markets. • Advise senior leadership on potential regulatory risks and opportunities, providing guidance to shape business strategies. • Oversee the development and review of product labeling to ensure accuracy, compliance with regulatory standards, and alignment with marketing claims. • Provide expertise in substantiating product claims (e.g., structure-function claims, health claims, etc.) and ensuring that marketing materials align with regulatory requirements. • Monitor, track, and report on emerging regulatory trends, proposed legislation, and changes in industry standards related to dietary supplements. • Work closely with R&D, marketing, legal, quality assurance, and supply chain teams to ensure compliance is maintained throughout the product development cycle. • Collaborate with external regulatory agencies and industry organizations to stay informed about regulatory issues affecting the industry and advocate for the company's interests. • Lead and mentor a team of regulatory affairs professionals, providing guidance on regulatory submissions, compliance requirements, and best practices. • Identify potential regulatory risks and provide strategic solutions to mitigate issues related to product formulations, claims, or compliance gaps. • Lead efforts to resolve non-compliance issues and manage corrective actions as necessary. • Work with legal counsel to resolve product compliance conflicts, and other issues when ambiguity exists in the regulations by applying risk management principles to ensure consumer and brand protection. • Conduct training sessions for internal teams on regulatory matters and compliance processes. • Coordinate internal audits to ensure compliance with regulatory standards and best practices.

🎯 Requirements

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Pharmacy, or similar). • Advanced degree (e.g., MS, MBA, or JD) is a plus. • Minimum of 7-9 years of regulatory affairs experience in the dietary supplement, food, or pharmaceutical industry, with at least 3 years in a leadership role. • Proven experience in managing regulatory submissions, labeling, and compliance for dietary supplements in the U.S. and international markets. • In-depth knowledge of FDA regulations, DSHEA (Dietary Supplement Health and Education Act), GRAS, NDI, and other relevant industry standards. • Experience in managing regulatory compliance for product claims, including structure-function claims and health claims. • Ability to interpret and communicate complex regulations in a clear, actionable manner.

🏖️ Benefits

• Full medical, dental, and vision benefits • Basic Life Insurance • 401(k) eligibility with company matching • Flexible Vacation and time off policy • $100/month wellness stipend • Paid holidays • Competitive compensation • Tuition reimbursement • Fringe benefits including free access to Onnit Academy gym ; co-pay healthy meals; among many others