Manager – Regulatory Affairs
Job Description:
• Stay current on FDA, FTC, and dietary supplement regulations relevant to ARMRA. Flag regulatory developments and potential impacts.
• Review and support approval of marketing materials, influencer content, and digital platforms to ensure claims are substantiated, truthful, and compliant.
• Assist with product labeling requirements, including supplement facts panels and allergen declarations, ensuring adherence to FDA compliance (21 CFR 101).
• Maintain regulatory documentation, including SOPs, substantiation dossier and claims source-of-truth file.
• Assist in the development of internal employee training and external education.
• Support the Sr. Manager with regulatory submissions, inquiries, and audits as needed.
• Assist in maintaining cGMP-compliant systems (21 CFR 111).
• Partner with Marketing, Science, & Growth teams to provide regulatory input and ensure alignment on claims and messaging.
• Act as a resource for compliance questions and escalate complex issues to the Sr.
Manager of Regulatory Affairs.
Requirements:
• Bachelor’s degree in Food Science, Chemistry, Biology, or related field required.
• 3–5 years of experience in regulatory affairs within the dietary supplement, cosmetics, personal care, or pharmaceutical industry.
• Strong understanding of FDA regulations (21 CFR 111 and 101) and FTC guidelines.
• Experience reviewing marketing claims or product labels for dietary supplements or CPG.
• Quick learner who can internalize compliance frameworks and apply them consistently across a high volume of content reviews.
• Comfortable working independently in a fast-paced, remote environment.
• Excellent written and verbal communication skills with strong attention to detail.
• Analytical thinker capable of interpreting and applying regulatory requirements.
• Proven ability to manage multiple projects and deadlines in a fast-paced environment.
• Highly collaborative, with strong interpersonal skills to partner across teams.
Benefits:
• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off
• Remote work options