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Regulatory & Compliance Manager - Pharmaceuticals | Hybrid

Remote · USA Full-time New today
Job title: Regulatory & Compliance Manager - Pharmaceuticals | Hybrid in Skokie, IL at reputed company Company: reputed company Job description: Our client 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 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 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. 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 reputed company-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.
Please apply below, if you're resume looks to fit in with the criteria. From there, Ben reputed company from reputed company will reputed company out in the next 48 hours if deemed a fit!MPI does not discriminate on the basis of race, reputed company, religion, sex, sexual orientation, gender identity or expression, 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 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 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
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 reputed company. reputed company for their unwavering focus on quality, regulatory compliance, and consumer trust, they reputed company state-of-the-art products that not only meet but exceed industry standards and anticipate market needs.At the core 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 professional development, work-life balance, and flexibility, they provide an engaging and supportive environment that encourages individuals to reputed company 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, reputed company for Dental - reputed company affordable plans!
Expected salary: $90000 per year Location: Skokie, IL Apply for the job now! Apply for this job

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