Senior Submission Manager, Global Regulatory Affairs Operations

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!

The role

The Senior Submission Manager is responsible for leading and managing global CTA submissions across the EU UK and Rest of World (excluding US and Japan) ensuring high-quality compliant deliverables and adherence to timelines. The role requires strong expertise in regulatory submission requirements health authority expectations and electronic submission systems.

Working closely with cross-functional teams this role drives alignment resolves issues and ensures submission readiness. Strong leadership communication and stakeholder management skills are essential along with the ability to operate independently and manage multiple priorities in a global environment.

Responsibilities

• Responsible for submission management of CTA applications across the EU UK and Rest of World (excluding US and Japan)
• Lead both initial and lifecycle CTA submissions including coordination of Rapid Response Teams and act as a liaison across multidisciplinary teams and contract research organizations
• Perform independent quality control of CTA submissions including review of submission documents and structured data within CTIS and other submission portals
• Maintain up-to-date knowledge of regulatory requirements and industry standards
• Serve as the Regulatory Operations representative on project teams collaborating with project managers regulatory leads and content authors to plan and drive submission timelines and deliverables
• Liaise with functional areas (Clinical Nonclinical CMC) to ensure documents are compliant and submission-ready; work closely with authors to resolve issues and ensure adherence to regulatory and company standards
• Identify regulatory risks and emerging issues and proactively develop mitigation strategies and solutions
• Ensure all regulatory content is appropriately tracked archived searchable and accessible within Document Management Systems
• Maintain working knowledge of regulations and processes governing controlled documents in accordance with Health Authority and ICH requirements
• Ensure adherence to submission timelines health authority publishing specifications and internal processes

Requirements .

• BA/BS degree or equivalent with a minimum of 68 years experience in the pharmaceutical industry including significant experience in Regulatory Affairs submissions
• In-depth knowledge of CTA requirements including lifecycle management and global submission strategies
• Strong understanding of health authority procedures and regulatory submission processes across regions
• Extensive hands-on experience with Electronic Document Management Systems (e.g. Veeva Vault RIM systems)
• Advanced proficiency in MS Office Suite and Adobe Acrobat
• Strong attention to detail with the ability to ensure high-quality compliant submission deliverables under tight timelines
• Strong Team player with excellent communication and stakeholder management skills with the ability to engage effectively across functions and seniority levels
• Highly self-motivated with the ability to take ownership drive submission activities independently and manage multiple priorities

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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