- Ensure site-level compliance with MOCRA requirements, including GMP alignment, record retention, adverse event handling, and inspection readiness.
- Act as the quality focal point for USFDA interactions, audits, and inspections.
- Support USFDA clearance of shipments and address documentation or compliance-related queries.
- Review raw material specifications, formulations, and finished products to ensure regulatory compliance.
- Ensure label review and compliance (ingredients, claims, warnings).
- Maintain inspection-ready documentation and support timely responses to regulatory observations and inquiries.
- Collaborate with R&D to support new product trials, scale-up, and technology transfer.
- Provide quality input on formula design, ingredient selection, packaging compatibility, and stability studies.
- Support troubleshooting, investigations, and process optimization.
- Ensure R&D documentation aligns with quality systems and regulatory expectations.
- Coordinate and support internal and external audits.
- Ensure continuous compliance with GMP, product quality, and regulatory standards.
- Manage and review supplier quality documentation.
- Support regulatory inspections and customer audits, including USFDA interactions.
- Drive initiatives to enhance product quality, operational efficiency, and cost optimization.
- Master's degree in Chemistry, Pharmacy, Biotechnology, Microbiology, or related discipline.
- 10–12 years of experience in Cosmetics, Personal Care, FMCG, or Pharmaceutical Manufacturing with US market exposure.
- Strong working knowledge of MOCRA, USFDA cosmetic regulations (21 CFR), GMP, and quality systems.
- Experience handling USFDA inspections, observations, and regulatory queries.
- Proficiency in ERP/SAP, QMS, Safety Data Sheets, and documentation control systems.
- Prior experience in R&D, validation, technology transfer, or NPD preferred.
- Knowledge of CPNP (EU), SCPN (UK), and global cosmetic regulations is an advantage.
- Strong analytical, documentation, communication, and stakeholder management skills.
- Quality leadership & decision-making
- Regulatory & compliance expertise
- Cross-functional collaboration
- Risk assessment & problem-solving
- Strong documentation & communication skills
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Manager - Regulatory & Quality for FMCG Client - Chicago - Walk In Solutions
Description
We have an exciting opportunity of Regulatory and Quality Manager with our FMCG client based in Chicago, USA
Job Title: Manager - Regulatory & Quality
Location: Chicago, USA
Reporting To: Head of Operations
Job Summary:
This role provides strong regulatory oversight to ensure compliance with MOCRA, USFDA Cosmetic regulations, and broader US market requirements, while supporting product development, technology transfer, and continuous improvement initiatives.
The role is also responsible for leading quality systems, quality operations, supplier quality, and audit readiness for all US-based products.
Key Responsibilities:
Regulatory & Market Compliance:
R&D and New Product Development:
Quality Assurance, Audit & Compliance:
Continuous Improvement:
Qualifications, Experience & Skills:
Key Competencies:
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