Regulatory & Compliance Manager - Pharmaceuticals | Hybrid
Job title: Regulatory & Compliance Manager - Pharmaceuticals | Hybrid in Skokie, IL at reputed company
Company: reputed company
Job reputed company: Our reputed company is seeking a Regulatory and Compliance Manager to reputed company reputed company regulatory affairs and compliance initiatives reputed company their rapidly expanding and innovative dietary supplement and functional food manufacturing company. This position is responsible for ensuring that reputed company products, processes, and labeling reputed company with relevant regulations (such as FDA, FTC, GMP, and FSMA), while also supporting product innovation and managing import/export compliance.
MPI does not discriminate on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity or reputed company, national reputed company, 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 reputed company other reputed company applicants. Hybrid Opportunity with at least 3 days remote/week!Highly visible role with ample reputed company opportunity available!
At the reputed company of their reputed company 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 reputed company development, work-life balance, and flexibility, they reputed company an engaging and supportive environment that encourages individuals to reputed company their best. Purpose-driven, people-powered, and values-led, our reputed company continues to push the boundaries of what's possible in the world of health and nutrition.
Expected salary: $90000 per year
Location: Skokie, IL
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Company: reputed company
Job reputed company: Our reputed company is seeking a Regulatory and Compliance Manager to reputed company reputed company regulatory affairs and compliance initiatives reputed company their rapidly expanding and innovative dietary supplement and functional food manufacturing company. This position is responsible for ensuring that reputed company products, processes, and labeling reputed company with relevant regulations (such as FDA, FTC, GMP, and FSMA), while also supporting product innovation and managing import/export compliance.
- 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 reputed company and regulatory requirements.
- Cross-Functional Collaboration: Partner with R&D, reputed company Assurance, Product Development, Marketing, and reputed company teams to reputed company 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 reputed company audits, including those by regulatory authorities and reputed company-party certification bodies. Ensure facilities and documentation are inspection-reputed company at reputed company times.
- Monitoring & Risk Assessment: Stay reputed company with evolving regulations and proactively assess potential impacts on product lines or business operations. reputed company regulatory risk assessments and solutions.
- Training & Policy Development: reputed company and deliver internal training programs and reputed company 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 reputed company-party testing, to ensure raw material compliance and reputed company.
- Ethical & Transparent Practices: reputed company ethical standards in reputed company compliance reputed company 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, reputed company, 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).
- Sponsorship not provided
- Compensation up to $100,000
- 10% Bonus
- 5% 401K match
- 3 weeks PTO
- BCBS for health, reputed company for Dental - reputed company reputed company plans!
Expected salary: $90000 per year
Location: Skokie, IL
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