Regulatory Manager

Distro

Completely RemoteFull TimeHealthcare & Telemedicine
Posted Today

Job description

Responsibilities

  • Conduct regulatory reviews of product labels, packaging, marketing materials, websites, social media content, and advertising claims
  • Evaluate claim substantiation and provide regulatory guidance to ensure compliance with FDA, FTC, and applicable industry regulations
  • Review formulas, ingredient specifications, SOPs, quality documentation, and compliance programs
  • Support regulatory strategy, product development initiatives, and due diligence activities for clients
  • Prepare and review regulatory reports, compliance assessments, and related documentation
  • Serve as a subject matter expert on food and dietary supplement regulations and emerging industry requirements
  • Partner with executive leadership to support the growth and development of the MRS department and future team members

Requirements

  • 12+ years of experience in Regulatory Affairs, Quality, Compliance, or related functions in food or dietary supplement industries
  • 8+ years of direct experience reviewing and approving food and dietary supplement labeling and claims
  • Advanced knowledge of FDA food labeling regulations (21 CFR Part 101)
  • Strong understanding of claim substantiation, compliance assessments, and regulatory risk evaluation
  • Excellent written and verbal communication skills
  • Experience managing projects, client relationships, and cross-functional initiatives

Preferred Qualifications

  • USDA labeling experience
  • Spanish language proficiency
  • Previous consulting experience supporting multiple clients and product categories
  • Experience leading, mentoring, or building regulatory teams

Skills & tools

Regulatory AffairsFDA Compliancefood safety

What the team is looking for

Use this list as a quick fit check before you apply.

  1. 0112+ years Regulatory Affairs experience
  2. 028+ years labeling and claims review experience
  3. 03Knowledge of 21 CFR Part 101
  4. 04Project management experience
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