Senior Manager, Global Regulatory Operations, Regulatory Systems

At Genmab we are dedicated to building extranotordinary 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.

o Monitor and respond to inquiries to RIMSupport inbox and general end user technical and process support

o Assist with periodic internal user review periodic external user review and annual audit trail

o Supporting RIM Registrations activities and verifications activities

Authoring Support activities

o Provide authoring support specifically Acumen templates which includes performing quality checks and converting documents to be compliant.

o Use Toolbox to assist with PDF submission-readiness

Minimum Requirements/Qualifications 8 years

• Bachelors degree required.
• Ideal candidate has a minimum of 8 yrs related experience (e.g. Regulatory Operations Systems)
• Veeva RIM System Administrator experience required preferably 4 years of experience; Veeva RIM System Administrator certification highly desirable
• Significant experience in regulatory submissions compliance business systems technology and process is required.
• Experience with global submissions and Health Authority portals in multiple markets (e.g US EU JP and ROW). Experience with xEVMPD is a plus.
• Demonstrates problem-solving ability flexibility and teamwork.
• Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging.
• Excellent organizational skills ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelines.
• Lorenz dB publishing tool experience is a plus.

About You

• 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!

Locations

Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.

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