Regulatory Affairs Senior Associate (Pre - Approval) - DEMO Global Services

About the role

The Regulatory Affairs Senior Associate will work at the interface of R&D and Regulatory, building a genuine technical understanding of the product's formulation and analytical profile to support sound regulatory strategy. This is not a document-processing role — it requires the ability to engage with development science, identify potential issues, and contribute informed regulatory thinking rather than just administrative submission support.

What you'll do

• Develop a working technical understanding of assigned products — formulation composition and rationale, manufacturing process
• Review R&D and Analytical data, including formulation trials, stability studies, method validation and characterization data, critically to spot gaps
• Support the Manager/Director in framing regulatory strategy by contributing well-reasoned technical inputs
• Assess the regulatory impact of significant development changes and ensure that comparability, bridging or additional evidence requirements are addressed prospectively
• Prepare and/or review assigned dossier sections, briefing packages and responses to major authority questions, ensuring completeness

What you need

• 4–7 yrs of experience
• Regulatory affairs
• Communication
• Any graduate