Assistant Manager, Regulatory Affairs

Job Description:

Responsibilities

• 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.

Qualification & Expeirnece

• M.Sc. Chemistry or M.Pharm
• Experience: 8 -15 yrs