Ms. Cook joins DRA as a Regulatory Operation Specialist, bringing in over 4 years of industry experience. With expertise in regulatory publishing, documentation management, and compliance, Ms. Cook excels in formatting, preparing, and compiling various submissions (IND, NDAs, BLAs, MAAs, and CTAs).
Previously, Ms. Cook worked at Premier Research, Pfizer and UNC Global health and infectious Disease Department gaining expert experience in IND and NDA publishing and maintenance, CMC, quality control, regulatory documentation, eCTD structure, project management, and training staff members.