Senior Submission Manager, Global Regulatory Affairs Operations

About 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 6-8 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
• Ab

Benefits

Additional Information

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!

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