Senior Regulatory Affairs Manager - Dietary Supplements

GummyWorks; West Palm Beach (FL); Presencial; USD 90.000 - 140.000; Tempo integral

Resumo da vaga

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

FDA Regulations

cGMP

Regulatory Submissions

Documentation Control

Audits & Inspections

Leadership

Communication

Formação

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

Ferramentas

Quality Management Software

Descrição da vaga

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.