RC-REGULATORY COMPLIANCE-Regulatory - SME-Senior Manager

About the role

We are seeking an experienced Manager with deep expertise in Regulatory Affairs to lead regulatory strategy and IT-enabled transformation initiatives in regulated GxP environments. This role requires strong consulting skills, industry knowledge, and the ability to translate regulatory strategy into scalable, compliant solutions for global clients.

What you'll do

• Lead global regulatory strategy development, ensuring compliance with FDA, EMA, MHRA, PMDA, and other health authorities
• Provide expert guidance on regulatory submissions, dossier preparation, and lifecycle management across multiple markets
• Drive RIMS implementation and optimization (e.g., Veeva Vault RIM) to improve data integrity and regulatory efficiency
• Design regulatory roadmaps aligning processes, technology, and operating models
• Support health authority interactions, responses to queries, and regulatory communications

What you need

• Compliance
• Regulatory affairs
• Machine learning
• GCP
• Documentation
• Capital markets

Good to have

• Go-to-market
• SAP
• Google Analytics
• Travel booking