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
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