Regulatory and Compliance Manager/Specialist
Job title: Regulatory and Compliance Manager/Specialist in Skokie, IL at Michael Page
Company: Michael Page
Job description: Our client is hiring for a Regulatory and Compliance Manager to oversee and lead all regulatory affairs and compliance functions within their fast-growing, innovative dietary supplement and functional food manufacturing company. This role is responsible for ensuring that all 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 Oversight: Ensure all products comply 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: Oversee 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: Lead internal and external audits, including those by regulatory authorities and third-party certification bodies. Ensure facilities and documentation are inspection-ready at all times.
- Monitoring & Risk Assessment: Stay current with evolving regulations and proactively assess potential impacts on product lines or business operations. Provide regulatory risk assessments and solutions.
- Training & Policy Development: Develop 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 continued compliance throughout the product lifecycle.
- Supplier & Ingredient Compliance: Oversee 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 all compliance matters and foster a culture of transparency, accountability, and continuous 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 related 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, Delta Dental for Dental - very affordable plans!
- More!