About The Role

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, good 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.

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Assistant Manager, Regulatory Affairs