Laura B. Grablutz

Ms. Laura Grablutz has >25 years of regulatory experience having worked on numerous successful drug applications and filings. She has held positions of increasing responsibility in worldwide regulatory affairs at Auxilium Pharmaceuticals, Genaera Corporation, and Centocor/JNJ. She worked on numerous successful biologics, small molecule, drug-device, and device combination product applications and filings. Her RA leadership encompassed from early development to post-marketing, Orphan drugs, CMC, labeling, advertising, and promotional review.