Senior Associate - Regulatory Affairs

About the role

Senior Associate - Regulatory Affairs at ClinChoice. Review and manage all regulatory events (changes) initiated within the Veeva Vault RIM system.

What you'll do

• Review and manage all regulatory events (changes) initiated within the Veeva Vault RIM system
• Perform system impact assessments for regulatory changes and ensure accurate documentation of outcomes
• Create and maintain regulatory Activities, Regulatory Objectives, Submissions, Global Content Plans, and associated records
• Ensure proper linkage and completeness of Event Details, Change Items, and Label Concepts within the system
• Support CMC Product Strategists, Labelling Leads, and Country Regulatory Strategists through both strategic and operational regulatory support

What you need

• 3–5 yrs of experience
• Regulatory affairs
• Data structures
• Data visualisation
• Power BI
• Tableau
• Quality control
• B.Sc or M.Sc or B.Pharm or M.Pharm

Good to have

• Reconciliation