7077 Regulatory Associate III
Author sections of BLA on the basis of PTR model documents and available source documentation in discussion and alignment with responsible subject matter experts (SMEs).
Authoring includes transfer and formatting of relevant data sections (without modifications) from source documents as well as contextual authoring of written content based on source documentation. Provide regulatory consideration as applicable.
General biologics manufacturing and testing background as well as prior experience as relates to BLA authoring.
Scientific degree, min 3 years of pharmaceutical industry relevant experience.