Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Evaluate and authorize commercial scripts, social media content, emails, and marketplace listings to ensure compliance with FDA and FTC regulations.

• Identify potentially risky claims and suggest compliant alternatives.

• Facilitate claims substantiation by reviewing and organizing evidence while keeping accurate records.

• Evaluate claims in relation to the standard of competent and reliable scientific evidence.

• Review supplement labels, packaging, and ingredient disclosures for compliance.

• Assist in the development of regulatory Standard Operating Procedures (SOPs), processes, and internal guidance documents.

• Conduct or assist with investigations and documentation related to Serious Adverse Event Reporting.

• Keep abreast of developments from the FDA, FTC, and NAD, including warning letters and pertinent industry litigation.

• Prepare and deliver regular industry updates to cross-functional teams.

• Collaborate with Marketing, R&D, Product Development, and Quality throughout the lifecycle of products.

• Oversee the company's trademark program, which includes initial searches, maintaining records, and coordinating with legal counsel for USPTO submissions.

⛳️ Requirements

• 2–3 years of experience in regulatory affairs related to dietary supplements.

• A working knowledge that product claims must be substantiated.

• Familiarity with FDA and FTC regulations concerning dietary supplements.

• Experience in reviewing labels and/or promotional materials for compliance purposes.

• Understanding of DSHEA, 21 CFR Part 111, and the fundamentals of structure/function claims.

• A Bachelor’s degree in a life science, food science, or a related field.

• Experience in direct-to-consumer (DTC) or eCommerce, including compliance with online marketplace platforms like Amazon.

• Proficiency in reviewing specifications or Certificates of Analysis (COAs).

• Experience in assisting with the development of SOPs or improving regulatory processes.

• Previous experience working with AI systems such as Claude and Notion AI.

• Must have legal authorization to work in the US for any employer.

• Willingness to work West Coast (PST) hours until 4:30 pm PST.

🏝️ Benefits

• Medical, Dental, Vision, and Life Insurance.

• Fully remote work opportunity.

• Monthly stipend for work-from-home expenses.

• Generous paid time off program.

• Employee discounts on products.