Skills
CTD/Regulatory document Review & Compilation
• Review Development/CMC data & Coordination
• Regulatory data & submissions management
• Product life-cycle management
• Optimist, Confident, Keen learner
• Time Management, Critical Thinking
• Strong verbal and written communication skills
• Well versed MS Word, MS excel, MS PowerPoint
Regulatory Guidelines/ ICH guidelines
• Managed responses to Health Authority queries
• Support in post approval changes
• Regulatory Project Management
• Microsoft Project Professional 2021
• Enthusiastic, Strong Work Ethic
• Efficient multi-tasker
About
Regulatory Affairs professional with 2 years of experience driving global and EU submissions, specializing in CTD (Modules 2 & 3) and CMC documentation. Assisted post-approval changes, lifecycle submissions, and respond to Health Authority queries with precision and accountability. Align regulatory strategies with global compliance requirements and ensure timely execution of projects across diverse markets. Apply sound regulatory judgment, collaborate effectively across departments, and deliver high-quality submissions in fast-paced environments. Committed to advancing regulatory operations, intelligence, and global compliance with accuracy, efficiency, and purpose.
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