* Scientific review of external API vendor’s DMFs in context of ANDA/NDA &
resolving any gaps.
* Preparation & review of ANDA/NDA Drug Substance Modules & related activities.
* Preparation of project status & updates for discussion in next level.
* Assessment of change controls & vendor notifications.
* Technical writing of deficiency responses, modules & other scientific
regulatory documents, as required.
* Participation in project meetings, coordination with CFTs, valuable communication
& coordination.
* Supporting Europe & Canada market due diligence 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.