Regulatory Affairs Manager
$130,000–$150,000 year
Remote · United States
Job Summary
Lead regulatory and compliance reviews for dietary supplements in a GMP environment, owning key workstreams across labeling, claims substantiation, ingredient documentation, and product review. Partner with cross-functional teams (Brand, Creative, Marketing) to translate regulatory requirements into clear guidance, develop and maintain SOPs, support GMP/QMS documentation, and drive compliance initiatives including FDA/FTC standards. This remote-first role emphasizes regulatory strategy, cross-functional collaboration, and continuous improvement of regulatory processes and automation to ensure compliant outputs across product development and brand initiatives.
Required Qualifications
- Minimum of 6 years experience in Regulatory Affairs in a GMP environment, with at least 4 executing technical regulatory reviews in dietary supplements for the U.S.
- Minimum B.Sc. in pharmaceutical, nutritional, or life sciences or a related scientific field.
- Experience in attaining and adhering to compliance with FDA regulations, including 21 CFR 111 and FSMA.
- Strong knowledge of the FDA regulatory landscape and enforcement discretion trends for dietary supplements.
- Experience with structure/function claim compliance and general FTC advertising rules
- Strong knowledge of GMP product documentation requirements
- Strong knowledge of dietary supplement labeling requirements
- Experience representing regulatory positions in cross-functional teams
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.