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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
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