Greenville, North Carolina, United States
Regulatory Professional with 17 years experience and 6 years in analytical development. Regulatory Experience with concentration with Modules 1, 2, and 3. Module 5 familiarity with reviews and content. My experience covers CMC, biologics, immediate release, modified release, steriles, transdermals, topicals, and OTC. Submissions: INDs, NDAs, BLA, Annual Reports, Amendments, Supplements, IMPDs, CTAs CBER and CDER QbR QOS Development Reports Labeling creation: PLR format, SPL CTD/eCTD submissions Drug Listings Establishment Registration NDC Site Self-Identification Familiar with electronic submissions and FDA ESG