in small molecule drug product development to support Chemistry, Manufacturing, and Controls (CMC) teams within our development... substance development, drug product formulation and process development, analytical method development and validation...
of aggregate data reports, and responses to regulatory agency requests. Strong knowledge of pharmacovigilance and drug development... for assigned investigational and/or marketed product(s) in partnership with the Safety Physician. The Sr. Pharmacovigilance...
biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery... and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers...
candidate will have a deep understanding of regulatory affairs related to generic drug development and dossier submission... agencies. Develop and implement regulatory strategies for generic product development, product modifications, and lifecycle...