Regulatory Affairs Manager

GummyWorks; West Palm Beach (FL); On-site; USD 90,000 - 140,000; Full time

Job summary

GummyWorks is seeking a Regulatory Affairs Manager in Florida to lead FDA/FTC compliance for dietary supplements. You will review labels, marketing materials, and product claims, ensuring DSHEA and GMP adherence while coordinating with R&D, QA, and Marketing to launch compliant products.

The role requires 2–5 years in regulated industries, strong regulatory knowledge, and experience with audits. Excellent communication is essential for cross-functional training and audits.

Qualifications

• Bachelor’s degree in a related scientific field.
• 2–5 years of regulatory affairs or quality experience in a GMP/FDA regulated industry.
• Strong working knowledge of 21 CFR Part 111, cGMP, FDA regulations, and quality systems.
• Experience managing audits and regulatory inspections.
• Excellent written and verbal communication skills.

Responsibilities

• Review and approve product labels, packaging, and marketing materials for FDA/FTC compliance.
• Ensure compliance with DSHEA and 21 CFR Part 111 (GMPs).
• Evaluate structure/function claims with proper disclaimers.
• Create and review product documentation and ingredient dossiers.
• Monitor regulatory changes and inform internal teams.
• Collaborate with R&D, Quality Assurance, and Marketing on compliant product development.
• Support audits, inspections, and regulatory inquiries.
• Assist with adverse event reporting and regulatory recordkeeping.
• Provide regulatory guidance and training to cross-functional teams.
• Perform other duties as assigned.

Skills

FDA Regulations

cGMP

Regulatory Submissions

Documentation Control

Audits & Inspections

Leadership

Communication

Education

Bachelor’s degree in Food Science/Quality Management/Biology/Chemistry

Tools

Quality Management Software

Job description

The Regulatory Affairs Manager is responsible for ensuring that all nutritional and dietary supplement products, labeling, documentation and marketing practices comply with applicable GMP, FDA, FTC, and other regulatory requirements. This role supports product development, customer document requests, reviews product claims and labeling, and ensures adherence to DSHEA, GMP, FDA standards, customer requirements and industry best practices.

Key Responsibilities:

• Review and approve product labels, packaging, and marketing materials to ensure compliance with FDA and FTC regulations
• Ensure compliance with DSHEA (Dietary Supplement Health and Education Act) and 21 CFR Part 111 (GMPs)
• Evaluate and substantiate structure/function claims, ensuring proper DISCLAIMERS and regulatory alignment
• Create, Maintain and review product documentation, including ingredient dossiers and specifications and other documentation as requested by management
• Monitor changes in regulatory requirements and communicate updates to internal teams
• Collaborate with R&D, Quality Assurance, and Marketing to ensure compliant product development and launch
• Support internal and external audits, inspections, and regulatory inquiries
• Assist with adverse event reporting and regulatory recordkeeping
• Provide regulatory guidance and training to cross-functional teams
• Perform other duties as assigned by management.

Qualifications:

• Bachelor’s degree in Food Science, Quality Management, Biology, Chemistry, or a related scientific field.
• 2-5 years of experience in regulatory affairs or quality in a GMP / FDA regulated industry (Dietary Supplement, Food, Cosmetics or Pharmaceutical Manufacturing)
• Strong working knowledge of 21 CFR Part 111, cGMP requirements, FDA regulations, and quality systems management.
• Experience managing audits and regulatory inspections.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills.
• Proficiency in document control systems and quality management software.

Additional Skills:

• Strong leadership and decision-making abilities.
• High problem-solving skills in fast-paced manufacturing environments.
• Ability to manage multiple priorities and meet deadlines.
• Analytical mindset with the ability to interpret regulations and apply them practically.
• Computing skills (Word, Excel, PowerPoint) to generate reports and maintain records.

Equal Opportunity Employer Statement: GummyWorks is an equal opportunity employer.We celebrate diversity and are committed to creating an inclusive environment for all employees.