Experience

Societal™ CDMO (formerly Recro)

• Regulatory Affairs Associate II

  • Jun 2003 - Present

  Provides support for Regulatory Affairs activities including but not limited to overseeing and facilitating the publishing and document archival (document management / pre-publishing / publishing) for US FDA submissions (NDAs, ANDAs, INDs, DMFs) such as SPLs, Annual Reports, Supplements (CBEs, PASs), Amendments, and ROW HA submission requests (i.e., GMP site clearance renewals, certification / registration / SMF requests). Coordinates and assigns site subscriptions (i.e., USP, Adobe) and provides oversight for RA CDAs, Establishment Registrations, USDA Permits, site licensing, PDUFA / GDUFA renewals, and Dunn & Bradstreet/IMS Finance reporting. Provides back-up support for Product Safety and Labeling activities within Regulatory Affairs at the Gainesville site Show less