Senior Manager, Regulatory Publishing

About Genmab

Genmab is an international biotechnology company dedicated to improving lives through innovative antibody therapeutics. We are committed to creating, championing, and maintaining a global workplace where unique contributions are valued, driving innovative solutions for patients, care partners, families, and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science.

The Role

Genmab is seeking a motivated individual to join a team committed to delivering quality submissions. As a Senior Manager, you will be responsible for activities related to regulatory publishing and submission management support for global health authorities including the FDA, EMA, MHRA, and SwissMedic. You will contribute to the innovation process, support the GRA strategy, and help implement new technology solutions for regulatory publishing business processes.

Responsibilities

• Create, assemble, and publish major and routine global electronic submissions (eCTD and NeeS), including MAA, BLAs, and INDs for Original Applications, DSURs, Supplements, and more.
• Serve as the global submissions expert, guiding teams on e-submission standards (eCTD, NeeS) and lifecycle management, while communicating regional regulatory differences.
• Perform QC and technical validation of electronic submissions to ensure compliance with internal and external standards before delivery.
• Adhere to required submission timelines, health authority publishing specifications, and internal working practices.
• Liaise with functional source areas (clinical, nonclinical, regulatory) to ensure document compliance with authoring style guides and regulatory/company specifications.
• Maintain working knowledge of regulations and processes governing controlled documents required by Health Authorities and ICH.
• Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.

Requirements

• BA/BS degree or equivalent.
• At least 8 years of pharmaceutical industry experience, with prior Regulatory Operations experience required.
• Knowledge of IND, BLA, MAA, regarding CTD requirements and guidelines for both eCTD and NeeS.
• Knowledge of industry trends in electronic submissions.
• Technical knowledge of electronic publishing systems and software.
• Proficiency with MS-Office Suite and Adobe Acrobat.
• Knowledge of health authority procedures/guidance regarding electronic submissions.
• Knowledge of Electronic Document Management Systems.
• Ability to balance multiple tasks to meet priorities and timelines.
• Self-starter with superior time management skills; ability to work independently or in teams.
• Strong attention to detail.
• Strong communication skills (oral and written).
• Submission management skills are a plus.

About You

• Genuinely passionate about Genmab's purpose.
• Bring precision and excellence to all endeavors.
• Believe in a science-rooted approach to problem-solving.
• A generous collaborator comfortable working in diverse teams.
• Take pride in enabling the best work of others.
• Able to grapple with the unknown and be innovative.
• Experience working in a fast-growing, dynamic company (or a strong desire to).
• Work hard and enjoy the process.

Locations

Genmab supports an agile working environment, offering flexibility for employee work-life balance. Work can be performed in office spaces or remotely, fostering connection and innovation.