A Regulatory Affairs Manager plans, directs, or coordinates production activities of an organization to ensure compliance with regulations and standard operating procedures.
Supplement and Cosmetic Regulatory Manager 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 Manager will be responsible for ensuring the legal and regulatory compliance of all dietary supplement and cosmetic products developed by the R&D team for contract manufacturing. This role requires a dynamic leader who can strategically navigate complex domestic and international compliance landscapes, supporting global supply chain operations and international sales while working closely with formulators to ensure speed-to-market. The ideal candidate will thrive in a fast-paced, collaborative environment, serving as the definitive regulatory voice within the innovation process for both client-driven projects and internal initiatives. Key Responsibilities
Compliance Oversight & Vetting:
Provide expert regulatory guidance on ingredient legality, dosage limits, and international compliance during the initial formulation stages to ensure products are compliant by design for both domestic markets and international sales. Monitor the compliance landscape to ensure internal policies and procedures are updated to new regulations in a timely manner.
Label & Claims Review:
Oversee the label approval process for 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), and adhere strictly to FDA, FTC, and global guidelines. Disposition existing labels based on the nature of a label or formula revision.
Documentation Approval:
Oversee the generation and maintenance of crucial compliance documentation including ingredient specifications, product specifications, Certificates of Analysis (COAs), New Dietary Ingredient (NDI) verifications, and cosmetic Product Information Files (PIF).
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:
o Minimum of 6+ years of progressive regulatory experience within dietary supplements, cosmetics, or a similarly regulated industry. o Minimum of 2+ years of experience in a management role, leading teams or managing complex projects from concept to commercialization. o 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.). Excellent leadership, project management, and problem-solving skills. 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:
$80,000.00 - $110,000.00 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
