Regulatory System Manager

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Senior International Consultant - Regulatory Affairs and Executive Search

Our client, a leading pharmaceutical company with multiple locations, is looking to hire a Regulatory Systems Manager, to lead the data management and strategy for RA systems.

As Regulatory Systems Manager, you will:

• Develop and drive the overall regulatory systems strategy, ensuring alignment with business objectives and regulatory requirements.
• Oversee the RIM, including routine maintenance, system validation, and collaboration with internal IT teams.
• Evaluate and implement new technologies to enhance regulatory processes and system efficiencies.
• Ensure ongoing updates and improvements to RIM and related processes as required by the business, as well as changes in regulatory guidance.
• Oversee submission management and publishing teams, including external vendors.
• Review vendor metrics, track performance, and manage service delivery expectations in coordination with regulatory and vendor management teams.
• Own regulatory data governance, ensuring accuracy, compliance, and alignment with business needs.

To be considered for the role of Regulatory Systems Manager, you will have the following experience/background:

• At least 5 years previous experience in regulatory operations, specifically data and system management.
• Must have previous experience with VEEVA RIM.
• Autonomous, able to plan, prepare, and execute a new regulatory system.
• Previous regulatory operations experience gained within a pharmaceutical company.

This is a permanent position with remote working options.

Seniority Level

• Mid-Senior level

Employment Type

• Full-time

Job Function

• Strategy/Planning and Information Technology

Industries

• Pharmaceutical Manufacturing and Biotechnology Research