Regulatory Consultant (CMC-EU, GCC & AU)

Overview

Regulatory Consultant responsible for CMC authoring and lifecycle management for small-molecule products across global and regional markets.

What you'll do

• Author CTD Module 3 sections independently.
• Prepare regulatory submission components, gap analyses, and product development plans.
• Prepare briefing packages and support regulatory agency interactions.
• Manage regulatory activities against agreed timelines, scope, budgets, and strategies.
• Support multidisciplinary teams throughout the product lifecycle.
• Defend CMC content in authority queries and troubleshoot project issues.
• Prepare training materials, support audits, and maintain regulatory documentation.

What you'll need

• Experience authoring CMC content from raw technical documents.
• Independent authorship experience with CTD Module 3 sections.
• Experience with post-approval variations or supplements.
• Experience working with analytical, formulation, and manufacturing teams.
• CMC writing and lifecycle management experience for small molecules.
• Knowledge of regulatory requirements across EU, USFDA, Australia, GCC, or other regions.
• Ability to identify when additional line support is required.

Details

• Remote role in India.