Regulatory Specialist
2 weeks ago
We are seeking a highly skilled and detail-oriented Regulatory Specialist for a large global Consumer goods company. As a Regulatory Specialist, you will play a crucial role in ensuring compliance with FDA regulations. Core responsibilities include but not limited to:
Regulatory submissions for FDA
Labeling Material Review
Development and Improvement of Quality Procedures
Implementation of updated Quality processes and regulations
SOP/GMP documentation
Quality and GMP compliance and FDA Audits.
Participated in FDA inspections
Managing complaints, nonconformance's, and CAPAs in accordance with regulatory requirements.
Skills:
- In-depth knowledge of FDA regulations, compliance, logistics, and supply chain operations
- Experience within consumer goods or pharmaceutical industry is preferred
- Attention to detail and accuracy in documentation; proficiency in Microsoft Office with strong Excel
- Strong communication skills, bilingual in English/Spanish is preferred
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