Senior Regulatory Affairs Specialist
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Successful Quality and Regulatory Affairs employee with proven expertise in regulatory affairs and compliance. Skilled at working with internal teams and agency representatives to address issues head-on. Knowledgeable about different areas of compliance and applicable guidelines. Stays on top of demands in fast-paced environments. Maintains organized, clean and safe work areas with diligent attention to important details. Dependable employee seeking opportunity to expand skills and contribute to company success. Considered hardworking, ethical and detail-oriented.
10 years of GMP and Pharmaceutical Manufacturing experience. Experience with FDA, GHA, EMA, TGA, and Canada Health. 7 years managerial experience.
Bachelors of Science from Central Washington University, Major: Biology