Regulatory & Quality Affairs Specialist

This is a remote position.

Our client is looking for aRegulatory & Quality Affairs Specialistto oversee compliance, regulatory documentation, and quality processes within their manufacturing operations. This role will serve as the regulatory authority across the product portfolio, ensuring that ingredients, formulations, labeling, and claims remain compliant with applicable regulations.

The company operates within the cosmetics and personal care manufacturing industry and has built a strong reputation in recent years for supporting brands with reliable product development and regulatory standards. In this position, the specialist will lead regulatory review and documentation processes while coordinating with laboratory and production teams responsible for hands-on testing and facility operations.

Responsibilities

• Review formulations, ingredients, and labeling to ensure compliance with FDA regulations, MoCRA requirements, and relevant international standards
• Monitor regulatory updates and assess how regulatory changes may affect current products
• Review marketing claims and packaging language to ensure they remain within cosmetic claim guidelines and avoid drug classification
• Provide guidance to internal teams and brand partners regarding compliant product positioning
• Build and maintain Product Information Files (PIFs), Certificates of Analysis (COAs), Safety Data Sheets (SDS), ingredient declarations, and technical documentation
• Prepare regulatory documentation packages for retailers, customers, and regulatory audits
• Complete compliance questionnaires, regulatory disclosures, and retailer submissions such as Sephora Clean, Ulta Clean, Vegan certifications, and EU documentation
• Maintain regulatory documentation related to raw materials and manage onboarding processes for new ingredients
• Review supplier documentation including COAs, specifications, allergen statements, and certifications
• Ensure ingredient listings remain FDA compliant and up to date
• Support quality management systems including GMP and ISO documentation requirements
• Maintain batch records and track deviations, nonconformances, and CAPA documentation
• Prepare audit-ready documentation for regulatory inspections and customer audits
• Coordinate with on-site laboratory teams regarding stability testing, microbiological testing releases, and inspection preparation

Requirements

• Bachelor’s degree in Chemistry, Biology, Regulatory Affairs, Pharmaceutical Science, Cosmetic Science, Law, or a related field
• Minimum of 5 years of experience in regulatory compliance, quality assurance, or documentation-intensive compliance roles
• Strong knowledge of FDA regulatory fundamentals
• Familiarity with MoCRA regulations, cosmetic labeling standards, or GMP frameworks preferred
• Professional-level written and verbal English required due to the documentation-heavy nature of the role
• Reliable high-speed internet connection and personal computer capable of supporting virtual desktop sessions

Qualifications

• Experience working in cosmetics, personal care, pharmaceutical, dietary supplement, food safety, or medical device industries
• Strong regulatory interpretation and compliance management skills
• Experience managing technical documentation and regulatory files
• Excellent attention to detail and strong documentation practices
• Ability to collaborate with cross-functional teams including laboratory, production, and commercial departments

Benefits

• Full-time position
• 100% remote role
• Opportunity to work with a well-established manufacturing organization supporting multiple beauty brands
• Exposure to international regulatory frameworks and retail compliance standards
• Collaborative environment focused on compliance, quality, and product safety

Originally posted on Himalayas