Scientific review of external API vendor’s DMFs in context of global ANDA/NDA & resolving any gaps.
Preparation & review of ANDA/NDA Drug Substance Modules for submission to FDA & related activities.
Participation in project meetings, coordination with CFTs, effective communication & coordination.
Supporting Europe & Canada market projects for Drug substance part, as required.
Knowledge of current regulatory guidelines is required.
Experience of complex APIs will add value.
Knowledge of using AI in routine work will add value.