Regulatory Specialist

Bright Innovation LabsNew Albany, OH

About The Position

SUMMARY / OBJECTIVE Supporting data entry and maintenance within Deacom, including creation and revision of Bills of Materials (BOM), Manufacturing Instructions, and In-Process/Finished Product specifications Maintaining and organizing technical documentation, including Master Files/Dossiers, Safety Data Sheets (SDS), Certificates of Analysis (CoA), and formula documentation Assisting in the preparation and drafting of regulatory documents (e.g., quantitative formulas, SDS, ingredient listings, and regulatory statements such as vegan certifications and allergen statements) Conducting research on raw material equivalency to support alternative sourcing recommendations Reviewing applicable regulatory requirements and guidance to support overall facility compliance Maintaining and updating the raw material regulatory document library ESSENTIAL FUNCTIONS The individual must be able to perform each essential function satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform these functions. Regulatory & Compliance Support Support evaluation of formulas, raw materials, and finished products for compliance with: Federal Food, Drug, and Cosmetic Act (FD&C Act) Modernization of Cosmetics Regulation Act of 2022 (MoCRA) Applicable OTC monographs Review and approve ingredient listings (INCI) to ensure compliance with U.S. regulations and customer-specific requirements Maintain awareness of current regulatory developments and communicate relevant updates internally Documentation & Data Management Perform data entry and management within Deacom (ERP/MRP system) Maintain regulatory master files, technical documentation, and product dossiers Prepare and support review of regulatory documentation, including SDS, quantitative formulas, and ingredient listings Ensure accuracy, completeness, and audit readiness of all documentation Route documents for review, approval, and signature in accordance with internal procedures Workflow & Cross-Functional Coordination Coordinate with cross-functional teams to complete WIP review workflows and other Deacom processes Support drafting and review of formulas and manufacturing procedures to ensure accuracy and timely completion Assist Regulatory and R&D leadership with assigned projects and compliance initiatives Raw Material & Supplier Compliance Review and approve raw material documentation, including: SDS, CoA, and technical data sheets Regulatory statements (e.g., allergen, vegan, RSPO) Maintain the approved raw material regulatory database Support sourcing decisions by identifying compliant raw material alternatives Regulatory Monitoring & Continuous Improvement Monitor changes in: U.S. cosmetic and OTC regulations Retailer-specific requirements (e.g., "clean" standards, restricted lists) International regulations (EU, Canada), as applicable Recommend updates to internal processes based on regulatory changes COMPETENCIES Strong understanding of cosmetic and OTC regulatory frameworks, including product classification and ingredient compliance Familiarity with INCI nomenclature and labeling requirements (U.S.; EU knowledge preferred) Experience with regulatory databases and documentation systems (ERP/PLM) High attention to detail with strong documentation accuracy Strong organizational, analytical, and time management skills Ability to interpret and apply regulatory requirements effectively Strong written and verbal communication skills Ability to manage multiple priorities in a fast-paced environment Proficiency in Microsoft Office (Word, Excel, Outlook) Basic math and unit conversion skills Additional requirements: Ability to work effectively under pressure Successful completion of background check and drug screening SUPERVISORY RESPONSIBILITIES This position has no supervisory responsibilities. CONSEQUENCES OF ERROR This role supports products and processes that scale to commercial manufacturing. Errors may result in compliance risks, quality issues, production delays, or customer impact. A high level of accuracy and attention to detail is essential. WORK ENVIRONMENT The work environment includes office, laboratory, and manufacturing settings. Employees may be exposed to fumes, airborne particles, and occasionally moving mechanical parts or chemicals. Noise levels are typically low to moderate. Appropriate safety protocols must be always followed. PHYSICAL DEMANDS Ability to sit, stand, and perform routine office and laboratory tasks Occasional walking, bending, and stooping Ability to distinguish colors and detect odors as required for product evaluation POSITION TYPE/EXPECTED HOURS OF WORK Full-time position, Monday through Friday Standard 8-hour workday Weekend work and overtime are not typically required TRAVEL No travel is expected for this position. REQUIRED EDUCATION & EXPERIENCE Bachelor's degree in chemistry, Biology, Regulatory Affairs, or a related scientific discipline 2–5 years of regulatory experience in cosmetics, personal care, or OTC products Contract manufacturing experience preferred PREFERRED QUALIFICATIONS Strong written and verbal communication skills Ability to interpret technical and regulatory documentation Bilingual (Spanish) is a plus Ability to perform basic mathematical calculations (e.g., ratios, percentages, unit conversions) ADDITIONAL ELIGIBILITY QUALIFICATIONS Proficiency in English, including grammar, composition, and technical writing Working knowledge of Microsoft Office (Word, Excel) and Adobe Acrobat

Requirements

  • Strong understanding of cosmetic and OTC regulatory frameworks, including product classification and ingredient compliance
  • Familiarity with INCI nomenclature and labeling requirements (U.S.; EU knowledge preferred)
  • Experience with regulatory databases and documentation systems (ERP/PLM)
  • High attention to detail with strong documentation accuracy
  • Strong organizational, analytical, and time management skills
  • Ability to interpret and apply regulatory requirements effectively
  • Strong written and verbal communication skills
  • Ability to manage multiple priorities in a fast-paced environment
  • Proficiency in Microsoft Office (Word, Excel, Outlook)
  • Basic math and unit conversion skills
  • Ability to work effectively under pressure
  • Successful completion of background check and drug screening
  • Bachelor's degree in chemistry, Biology, Regulatory Affairs, or a related scientific discipline
  • 2–5 years of regulatory experience in cosmetics, personal care, or OTC products
  • Proficiency in English, including grammar, composition, and technical writing
  • Working knowledge of Microsoft Office (Word, Excel) and Adobe Acrobat

Nice To Haves

  • Contract manufacturing experience preferred
  • Strong written and verbal communication skills
  • Ability to interpret technical and regulatory documentation
  • Bilingual (Spanish) is a plus
  • Ability to perform basic mathematical calculations (e.g., ratios, percentages, unit conversions)

Responsibilities

  • Supporting data entry and maintenance within Deacom, including creation and revision of Bills of Materials (BOM), Manufacturing Instructions, and In-Process/Finished Product specifications
  • Maintaining and organizing technical documentation, including Master Files/Dossiers, Safety Data Sheets (SDS), Certificates of Analysis (CoA), and formula documentation
  • Assisting in the preparation and drafting of regulatory documents (e.g., quantitative formulas, SDS, ingredient listings, and regulatory statements such as vegan certifications and allergen statements)
  • Conducting research on raw material equivalency to support alternative sourcing recommendations
  • Reviewing applicable regulatory requirements and guidance to support overall facility compliance
  • Maintaining and updating the raw material regulatory document library
  • Support evaluation of formulas, raw materials, and finished products for compliance with: Federal Food, Drug, and Cosmetic Act (FD&C Act), Modernization of Cosmetics Regulation Act of 2022 (MoCRA), Applicable OTC monographs
  • Review and approve ingredient listings (INCI) to ensure compliance with U.S. regulations and customer-specific requirements
  • Maintain awareness of current regulatory developments and communicate relevant updates internally
  • Perform data entry and management within Deacom (ERP/MRP system)
  • Maintain regulatory master files, technical documentation, and product dossiers
  • Prepare and support review of regulatory documentation, including SDS, quantitative formulas, and ingredient listings
  • Ensure accuracy, completeness, and audit readiness of all documentation
  • Route documents for review, approval, and signature in accordance with internal procedures
  • Coordinate with cross-functional teams to complete WIP review workflows and other Deacom processes
  • Support drafting and review of formulas and manufacturing procedures to ensure accuracy and timely completion
  • Assist Regulatory and R&D leadership with assigned projects and compliance initiatives
  • Review and approve raw material documentation, including: SDS, CoA, and technical data sheets, Regulatory statements (e.g., allergen, vegan, RSPO)
  • Maintain the approved raw material regulatory database
  • Support sourcing decisions by identifying compliant raw material alternatives
  • Monitor changes in: U.S. cosmetic and OTC regulations, Retailer-specific requirements (e.g., "clean" standards, restricted lists), International regulations (EU, Canada), as applicable
  • Recommend updates to internal processes based on regulatory changes
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