Regulatory Specialist

Responsibilities

· Create and apply documentation and control systems as required for regulatory areas;

· Continuously improve work processes, productivity and control systems as required for regulatory areas;

· Analyze test data from Raw material testing, Quality Control bulk testing, Stability testing and finished goods testing to determine the product release;

· Research applicable regulations;

· Compile and submit product review reports;

· Write and review the standard operating procedures, protocols, test methods and quality manuals;

· Document the Out-of-Specification, Out-of-Trend, Deviations and perform investigation to determine the root cause;

· Train staff on cGMPs (Current Good Manufacturing Practices), procedure and policy changes;

· Provide oversight of cGMP program and document control;

· Ensure compliance with regulatory, chemical, and safety requirements; Assist in compilations of Food and Drug Administration (FDA) Investigational New Drug Application submissions, write as directed sections and modules of a Common Technical document dossier;

· Provide on-going, daily regulatory and technical support to R&D, Marketing, Sales, and Customers;

· Compile health authority product notification; Research applicable regulations; Verify correct and up-to-date ingredient listed for all finished goods;

· Conduct raw material and formula reviews and assessments;

· Ensure product licenses and dossiers are updated and variations filed in a timely manner;

· Assist FDA inspection and customer audits.

· Must have a Master’s degree in Chemistry, Pharma Chem, or Related + 6 months professional experience as a Quality Control Tech or related.

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