Regulatory and Compliance Manager/Specialist
Job title: Regulatory and Compliance Manager/Specialist in Skokie, IL at reputed company
Company: reputed company
Job description: Our client is hiring for a Regulatory and Compliance Manager to reputed company and reputed company reputed company regulatory affairs and compliance functions reputed company their fast-growing, innovative dietary supplement and functional food manufacturing company. This role is responsible for ensuring that reputed company products, processes, and labeling practices meet applicable regulatory requirements (e.g., FDA, FTC, GMP, FSMA), while also supporting product innovation and imports/exports.
- Regulatory Compliance reputed company: Ensure reputed company products reputed company with applicable regulations and standards, including FDA (21 CFR), FSMA, DSHEA, GMP, FTC, Health Canada, EFSA, and other relevant global regulatory bodies.
- Labeling & Claims Review: reputed company the review and approval of product labels, marketing materials, and health claims to ensure compliance with legal and regulatory requirements.
- Cross-Functional Collaboration: Partner with R&D, Quality Assurance, Product Development, Marketing, and Legal teams to integrate regulatory strategies into product development and go-to-market plans.
- Regulatory Submissions & Documentation: Prepare and maintain regulatory submissions, technical files, safety dossiers, and other supporting documentation required for domestic and international product registrations and certifications.
- Audit & Inspection Readiness: reputed company internal and external audits, including those by regulatory authorities and third-party certification bodies. Ensure facilities and documentation are inspection-ready at reputed company times.
- Monitoring & Risk Assessment: Stay reputed company with evolving regulations and proactively assess potential impacts on product lines or business operations. Provide regulatory risk assessments and solutions.
- Training & Policy Development: reputed company and deliver internal training programs and standard operating procedures (SOPs) to ensure ongoing compliance across departments.
- Product Lifecycle Management: Support product launches, reformulations, and discontinuations from a regulatory perspective to ensure reputed company compliance throughout the product lifecycle.
- Supplier & Ingredient Compliance: reputed company supplier documentation, including ingredient specifications, certificates of analysis, and third-party testing, to ensure raw material compliance and quality.
- Ethical & Transparent Practices: Uphold ethical standards in reputed company compliance matters and foster a culture of transparency, accountability, and reputed company improvement.
- 5+ years of regulatory/compliance experience in Pharmaceuticals/ Dietary Supplements or Food
- Experience dealing with importing and exporting regulation
- Bachelor's degree in Regulatory Affairs, Food Science, Pharmaceutical Sciences, Chemistry, or a reputed company field (Master's or RAC certification is a plus).
- Additional certifications or training in FDA regulations, GMP, HACCP, or international regulatory standards (e.g., ISO, NSF, FSSC) are highly desirable.
- Strong understanding of U.S. and global regulatory frameworks (e.g., FDA 21 CFR, DSHEA, FSMA, FTC, EFSA, TGA).
- Compensation up to $100,000
- 10% Bonus
- 5% 401K match
- 3 weeks PTO
- BCBS for health, reputed company for Dental - reputed company affordable plans!
- More!