RA Senior Associate

About the role

As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. The Senior associate provides subject matter expertise in Regulatory Information Management (RIM) systems and processes within Global Regulatory Affairs (GRA).

What you'll do

• Maintain and manage data within Regulatory Information Management (RIM) systems like Veeva Vault. Create, update, and maintain regulatory records within Veeva Vault RIM
• Ensure activities comply with company SOPs, regulatory requirements, and data governance standards
• Work closely with Submission Management, Labeling, Publishing, Quality, and IT teams. Lead and collaborate on cross-functional initiatives to implement regulatory…
• Support the implementation of regulatory initiatives like XeVMPD, IDMP, and others. Strong working knowledge of Veeva Vault systems
• Good time management, prioritization, and attention to detail. Strong analytical, problem-solving, and critical-thinking abilities

What you need

• Compliance
• SOP writing
• Regulatory affairs
• Any graduate

Good to have

• Documentation