Senior Manager, Global Regulatory Operations - Remote

About the Role

We are looking for a Senior Manager, Global Regulatory Operations to join our team at Genmab. This Senior Manager, Global Regulatory Operations remote position is pivotal in supporting and optimizing core Regulatory Operations systems, including Veeva Vault RIM, Toolbox, and Acumen Authoring Tool. You will ensure effective system governance, data integrity, compliance, and end-user support while partnering cross-functionally to enable efficient regulatory submissions, registrations, and lifecycle management activities across global markets.

What You'll Do

• Support the Vault RIM system by creating and participating in deviations, CAPAs, Change Controls, and projects related to Regulatory Operations.
• Collaborate with the Digital Enablement team for configuration testing, UAT creation, and deployment into sandboxes and PROD environments.
• Develop reports for stakeholders and perform impact assessments on reports due to system enhancements.
• Attend Core team meetings and prioritize changes from upcoming Veeva releases and enhancements.
• Process and triage access request tickets to the RIM Vault and manage backlog change log items.
• Monitor Application Join creation and ensure eCTD data meets standardization and compliance requirements.
• Provide ad hoc training and hands-on support for end users.
• Assist with periodic internal user reviews and annual audit trails.

Requirements

• Bachelor's degree required.
• Minimum of 8 years of related experience in Regulatory Operations Systems, with at least 4 years of experience with Veeva RIM.
• Significant experience in regulatory submissions, compliance, and business systems technology.
• Experience with global submissions and Health Authority portals in multiple markets (e.g., US, EU, JP).
• Excellent verbal and written communication skills, capable of preparing effective presentations.
• Strong organizational skills with the ability to multitask and manage multiple projects within assigned timelines.
• Experience with Lorenz dB publishing tool is a plus.

Nice to Have

• Experience with xEVMPD.
• Demonstrates problem-solving ability, flexibility, and teamwork.
• Experience working in a fast-growing, dynamic company.

What We Offer

• Competitive salary and benefits package.
• Flexible work arrangements, allowing for remote work 20%-40% of the time.
• Opportunities for professional development and growth.
• A collaborative and innovative work environment.
• Access to cutting-edge technology and resources.