Assistant Manager, Regulatory Affairs
Amneal Pharmaceuticals
Qualification: M.Sc. Chemistry or M.Pharm
Experience: 8 -15 yrs
- 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.