Regulatory Affairs Specialist

About The Role

We're looking for a Regulatory Affairs Specialist to support compliance across our dietary supplement product lines. Reporting to the Regulatory Affairs Manager, you'll help ensure our labels, claims, and promotional materials meet FDA and FTC requirements — reviewing and interpreting regulatory standards, keeping documentation organized, and flagging risk before it reaches the market.

This is a hands-on, detail-driven role for someone who already knows their way around the dietary supplement space. You understand that claims have to be substantiated — that we can't just say things — and that supplements operate under real regulatory constraints. You'll work closely with Marketing, R&D, Product Development, and Quality as part of a small, high-trust regulatory team, with room to deepen your expertise over time.

What You'll Do

Claims & Promotional Review

• Review and approve promotional materials — commercial scripts, social media content, email, and marketplace listings — for compliance with FDA and FTC standards.
• Apply structure/function and advertising requirements to flag risky language and recommend compliant alternatives.
• Help ensure product claims are properly supported before they go live.

Substantiation Support

• Support the claims substantiation process by reviewing and organizing supporting evidence and maintaining substantiation records.
• Understand and apply the "competent and reliable scientific evidence" standard to assess whether a claim is adequately backed.

Labeling, SOPs & Compliance

• Review supplement labels to ensure packaging and ingredient disclosures meet applicable requirements.
• Assist in developing and maintaining regulatory SOPs, processes, and internal guidance.
• Conduct or assist with Serious Adverse Event Reporting (SAER) investigations and documentation.

Monitoring & Cross-Functional Partnership

• Monitor evolving FDA, FTC, and NAD developments — including warning letters and relevant industry litigation — and translate them into practical takeaways for the business.
• Prepare and present industry updates at recurring team meetings (e.g., a monthly regulatory round-up), keeping cross-functional partners aware of what's happening and why it matters.
• Partner with Marketing, R&D, Product Development, and Quality to provide practical regulatory guidance throughout the product lifecycle.
• Manage the company’s trademark program: conduct initial trademark searches, maintain records, and coordinate with legal counsel for USPTO submissions.

Who You Are

You care about getting the details right, and you understand that good compliance protects the brand and the customer. You're a partner to the business, not a gatekeeper.

• Detail-Oriented: You care about the details — because you know they add up to better, more trustworthy outcomes.
• Clear Communicator: You express ideas clearly and make regulatory concepts easy to understand for non-regulatory teammates.
• Organized & Deadline-Driven: You keep meticulous records and juggle competing priorities with ease, knowing that timely, well-organized documentation often gates product release.
• Proactive: You anticipate needs, take ownership, and ask for support when needed.
• Empowered Collaborator: You work across teams with trust and respect, and move projects forward through collective effort.

What You'll Need

• 2–3 years of regulatory affairs experience in dietary supplements — this is our top priority. Not a first regulatory job, but not a senior-level tenure either.
• A working understanding that product claims must be substantiated and that supplements operate under FDA and FTC regulation.
• Experience reviewing labels and/or promotional materials for compliance.
• Familiarity with DSHEA, 21 CFR Part 111, and structure/function claim basics.
• Bachelor's degree in a life science, food science, or related field.

Preferred

• Exposure to adjacent categories — cosmetics (MoCRA) or food/beverage — is a plus, though dietary supplement experience matters most.
• DTC or eCommerce experience, including online marketplace (e.g., Amazon) compliance.
• Comfort with quality or product documentation basics — reviewing specifications or Certificates of Analysis (COAs) and meeting the documentation timelines that gate product release.
• Experience assisting with SOP development or regulatory process improvement.
• Prior experience working within AI systems (Claude, Notion AI, etc.).