Assistant Manager, Regulatory Affairs

RXinsider LTD.; India; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

RXinsider LTD. is seeking a regulatory professional with 8–15 years experience in API review to manage DMF assessments and regulatory submissions for ANDA/NDA. The role involves preparing drug substance modules, coordinating with cross-functional teams, and ensuring compliance with current guidelines.

Knowledge of AI tools in regulatory work is considered an added value. This position requires strong technical writing and clear communication across Europe and Canada markets as needed.

Qualifications

• M.Sc. Chemistry or M.Pharm required.
• 8–15 years of regulatory affairs and API review experience.
• Experience with ANDA/NDA submissions and drug substance modules.
• Knowledge of regulatory guidelines and compliance.

Responsibilities

• Scientific review of external API vendor’s DMFs in context of ANDA/NDA.
• Preparation and review of ANDA/NDA Drug Substance Modules.
• Prepare project status updates for discussion at the next level.
• Assess change controls and vendor notifications.
• Technical writing of deficiency responses and regulatory documents.
• Participation in project meetings and coordination with CFTs.
• Support Europe & Canada market due diligence for Drug Substance.
• Knowledge of current regulatory guidelines; AI in routine work a plus.

Skills

Regulatory review

Technical writing

API knowledge

Team coordination

Communication

Education

M.Sc. Chemistry

M.Pharm

Job description

Job Description

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.