Craig M. Audet is Director/Team Leader for the Metabolic Products Group in Worldwide Regulatory Strategy at Pfizer Inc., where he is responsible for oversight of global regulatory maintenance for marketed products and regulatory strategy for new products. He directs activities relating to U.S. and worldwide regulatory matters for drugs and medical devices, including regulatory chemistry, manufacturing and controls, clinical trial submissions, labeling, advertising & promotion, new product development, and product defense strategies. Craig has over 17 years of industry regulatory experience and has dealt with FDA on Medical Device PMA, IND, and 510(k) submissions and Drug Master Files, INDs, NDAs and sNDAs.

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