Assistant Manager, Regulatory Affairs

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.