Regulatory Specialist
EmergencyMD, Beech Bottom, WV, United States
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
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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
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