Regulatory Specialist

Bright Innovation Labs•New Albany, OH

10d•Onsite

About The Position

The Regulatory Specialist supports data entry and maintenance within Deacom, including the creation and revision of Bills of Materials (BOM), Manufacturing Instructions, and In-Process/Finished Product specifications. This role involves maintaining and organizing technical documentation such as Master Files/Dossiers, Safety Data Sheets (SDS), Certificates of Analysis (CoA), and formula documentation. The specialist assists in preparing and drafting regulatory documents like quantitative formulas, SDS, ingredient listings, and regulatory statements (e.g., vegan certifications, allergen statements). Key responsibilities include conducting research on raw material equivalency for alternative sourcing, reviewing applicable regulatory requirements for facility compliance, and maintaining the raw material regulatory document library. The position also involves evaluating 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), and applicable OTC monographs. The specialist will review and approve ingredient listings (INCI) for U.S. regulations and customer requirements, stay updated on regulatory developments, and perform data entry in Deacom. They will coordinate with cross-functional teams for WIP review workflows, support drafting and review of formulas and manufacturing procedures, and assist Regulatory and R&D leadership with projects. Additionally, the role includes reviewing and approving raw material documentation (SDS, CoA, technical data sheets, regulatory statements), maintaining the approved raw material regulatory database, and supporting sourcing decisions. Continuous monitoring of U.S. cosmetic and OTC regulations, retailer-specific requirements, and international regulations (EU, Canada) is also part of the role, with recommendations for internal process updates based on these changes.

Requirements

Strong understanding of cosmetic and OTC regulatory frameworks, including product classification and ingredient compliance
Familiarity with INCI nomenclature and labeling requirements (U.S.)
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

Familiarity with EU INCI nomenclature and labeling requirements
Contract manufacturing experience
Bilingual (Spanish) is a plus

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