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Jared Gordon
Partner, Architecture

Eduardo Page
Senior Architect

Nina Bennett
Architect

Claribel Conroy
Architect

Caleb Romero
Senior Designer

Jamie Harris
Senior Designer

Traci Greene
Designer

Ana Nikolaidis
Designer

Michele Kovacs
Designer

Lucas Fletcher
Photographer

Amir Thakur
Business Development

Santiago Roy
Business Development

Odell Tyner
Business Development

Tom Hogan
IT Manager

Angelica Erickson
Office Manager

 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.

Apply