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.

REQUIREMENTS
– M.Sc. Chemistry or M.Pharm
– 8 -15 yrs of experience
– Knowledge of current regulatory guidelines
– Experience of complex APIs
– Knowledge of using AI in routine work