A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
Supplement and Cosmetic Regulatory Specialist Location:
Akron, OH (JetPack Shipping)
Reports To:
Director of Research and Development Job Type:
Full-Time Salary On-Site (Hybrid available) Job Overview The Regulatory Specialist acts as an individual contributor to the R&D team for contract manufacturing. This role is responsible for ensuring the legal and regulatory compliance of all dietary supplement and cosmetic products developed by the R&D team. The ideal candidate thrives in a fast-paced, collaborative environment and will serve as a strong regulatory voice within the innovation process.
Provide regulatory guidance on ingredient legality, dosage limits, and compliance during the initial formulation stages to ensure products are compliant by design. Monitor the compliance landscape to ensure internal procedures are updated to new regulations in a timely manner.
Label & Claims Review:
Approve client-provided labels for supplements and cosmetics, ensuring "Supplement Facts" panels, INCI (International Nomenclature of Cosmetic Ingredients) lists, Warnings (e.g., FALCPA, Prop 65, Structure/Function), adhere strictly to FDA, FTC, and global guidelines.
Specification Approval:
Approve ingredient specifications, product specifications, Certificates of Analysis (COAs), New Dietary Ingredient (NDI) verifications, and cosmetic Product Information Files (PIF) in accordance with the appropriate regulations.
Cross-Functional Collaboration:
Serve as a regulatory liaison, coordinating closely with R&D, Accounts, Quality, and Purchasing to resolve compliance challenges and bottlenecks before pilot batches move to commercial scale. Support Quality during any certification audits or regulatory body inquiries.
Qualifications Education:
A Bachelor's of Science in a related discipline is required. Additional certification in regulatory or business management preferred.
Experience:
Minimum of 3+ years of progressive regulatory experience within dietary supplements, cosmetics, or a similarly regulated industry. Experience in a contract manufacturing (private label) environment is a significant asset.
Skills:
Expertise in FDA (21 CFR Part 101, MoCRA) and California (Prop65) labeling requirements and a strong understanding of both dietary supplement and cosmetic ingredient legalities. Comprehensive knowledge of relevant domestic and global regulatory and safety landscapes (FDA, c
GMP 21 CFR
Part 111, Health Canada, FSANZ, ISO Cosmetic Regulation, etc.). Ability to clearly articulate regulatory requirements, risks, and solutions between R&D, Accounts, Quality, and Purchasing teams. Proficiency in business software, Email/Word/Excel/AI/ERP systems.
Pay:
$60,000.00 - $90,000.00 per year
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Health savings account Life insurance Paid parental leave Paid time off Vision insurance
