Senior Manager, Global Regulatory Operations, Regulatory Systems

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

Senior Manager, Global Regulatory Operations, Regulatory Systems

This role is responsible for supporting and optimizing core Regulatory Operations systems, including Veeva Vault RIM, Toolbox, Acumen Authoring Tool, and associated health authority portals. The position ensures 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.

Work arrangement: This role offers flexibility to work away from the office for 20%-40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.

Responsibilities:

• Vault RIM Vault system support:

o Create and/or participate in deviations, CAPAs, Change Controls, and projects related to Regulatory Operations and Veeva RIM Vault

o Partner with Digital Enablement team for configuration testing, UAT creation and developments, and deployment into sandboxes and PROD environments

o Develop reports for stakeholders, perform impact assessments on reports due to system enhancements, and execute updates as necessary

o Attend Core team meetings and prioritizing changes from upcoming Veeva releases and enhancements

o Process and triage access request tickets to the RIM Vault, ticket requests for changes and support, and working on backlog change log items

• Vault RIM Business Administrator activities:

o Process requests and create Master Data in the RIM Vault while meeting data governance criteria

o Monitor Application Join creation and ensure eCTD data is meeting standardization and compliance requirements, following up with end users as necessary

o Providing ad hoc training and hands-on support for end users

o Supports SOP and WI authoring, reviewing and approver as needed. Coordinate updates and creations of eLearnings.

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!