Regulatory & Compliance Manager - Pharmaceuticals | Hybrid
Job title: Regulatory & Compliance Manager - Pharmaceuticals | Hybrid in Skokie, IL at Michael Page
Company: Michael Page
Job description: Our client is seeking a Regulatory and Compliance Manager to lead all regulatory affairs and compliance initiatives within their rapidly expanding and innovative dietary supplement and functional food manufacturing company. This position is responsible for ensuring that all products, processes, and labeling comply with relevant regulations (such as FDA, FTC, GMP, and FSMA), while also supporting product innovation and managing import/export compliance.
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.
Please apply below, if you're resume looks to fit in with the criteria. From there, Ben Aldrich from Michael Page will reach out in the next 48 hours if deemed a fit!MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.Hybrid Opportunity with at least 3 days remote/week!Highly visible role with ample growth opportunity available!
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).
Sponsorship not provided
Our client is an innovative manufacturer operating at the crossroads of pharmaceuticals, dietary supplements, and functional foods, committed to advancing health and wellness through science, innovation, and integrity. Known for their unwavering focus on quality, regulatory compliance, and consumer trust, they develop state-of-the-art products that not only meet but exceed industry standards and anticipate market needs.At the core of their success is a people-centered culture. They view their employees as their most valuable resource, cultivating a workplace where creativity thrives, collaboration is seamless, and every team member is empowered to grow. With a strong emphasis on professional development, work-life balance, and flexibility, they provide an engaging and supportive environment that encourages individuals to achieve their best.Purpose-driven, people-powered, and values-led, our client continues to push the boundaries of what's possible in the world of health and nutrition.
Compensation up to $100,000
10% Bonus
5% 401K match
3 weeks PTO
BCBS for health, Delta Dental for Dental - very affordable plans!
Expected salary: $90000 per year
Location: Skokie, IL
Apply for the job now!
Apply Now
Company: Michael Page
Job description: Our client is seeking a Regulatory and Compliance Manager to lead all regulatory affairs and compliance initiatives within their rapidly expanding and innovative dietary supplement and functional food manufacturing company. This position is responsible for ensuring that all products, processes, and labeling comply with relevant regulations (such as FDA, FTC, GMP, and FSMA), while also supporting product innovation and managing import/export compliance.
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.
Please apply below, if you're resume looks to fit in with the criteria. From there, Ben Aldrich from Michael Page will reach out in the next 48 hours if deemed a fit!MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.Hybrid Opportunity with at least 3 days remote/week!Highly visible role with ample growth opportunity available!
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).
Sponsorship not provided
Our client is an innovative manufacturer operating at the crossroads of pharmaceuticals, dietary supplements, and functional foods, committed to advancing health and wellness through science, innovation, and integrity. Known for their unwavering focus on quality, regulatory compliance, and consumer trust, they develop state-of-the-art products that not only meet but exceed industry standards and anticipate market needs.At the core of their success is a people-centered culture. They view their employees as their most valuable resource, cultivating a workplace where creativity thrives, collaboration is seamless, and every team member is empowered to grow. With a strong emphasis on professional development, work-life balance, and flexibility, they provide an engaging and supportive environment that encourages individuals to achieve their best.Purpose-driven, people-powered, and values-led, our client continues to push the boundaries of what's possible in the world of health and nutrition.
Compensation up to $100,000
10% Bonus
5% 401K match
3 weeks PTO
BCBS for health, Delta Dental for Dental - very affordable plans!
Expected salary: $90000 per year
Location: Skokie, IL
Apply for the job now!
Apply Now