Senior Manager, Global Regulatory Operations, Publisher

Senior Manager, Global Regulatory Operations

Genmab is a global biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. We are seeking a motivated Senior Manager to join our team committed to delivering quality submissions and contributing to groundbreaking cancer treatments.

About the Role

As a Senior Manager, Global Regulatory Operations, you will be responsible for a range of activities supporting regulatory publishing and submission management for health authorities worldwide, including the FDA, EMA, MHRA, and SwissMedic. You will play a key role in driving innovation within the GRA strategy and supporting the implementation of new technologies for regulatory publishing processes.

Key Responsibilities

• Lead the creation, assembly, and publishing of major and routine global electronic submissions (eCTD and NeeS), including Marketing Authorization Applications (MAA), Biologics License Applications (BLA), and Investigational New Drug (IND) applications for original submissions, annual reports (DSURs), supplements, and more.
• Act as the global submissions expert, providing guidance to teams on e-submission standards (eCTD, NeeS) and lifecycle management, while effectively communicating regional regulatory differences.
• Perform quality control (QC) and technical validation of electronic submissions to ensure compliance with internal standards and external criteria before internal review and approval.
• Ensure adherence to required submission timelines, health authority publishing specifications, and internal working practices.
• Liaise with functional source areas (clinical, nonclinical, regulatory) to ensure documents comply with authoring style guides and regulatory/company guidance.
• Maintain a working knowledge of regulations and processes governing the content and maintenance of controlled documents required by Health Authorities and ICH.
• Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.

Requirements

• Bachelor of Arts/Science degree or equivalent.
• At least 8 years of experience in the pharmaceutical industry, with prior experience in Regulatory Operations.
• Knowledge of IND, BLA, and MAA requirements and guidelines for both eCTD and NeeS formats.
• Understanding of industry trends in electronic submissions.
• Technical proficiency with electronic publishing systems and software.
• Proficiency in MS-Office Suite and Adobe Acrobat.
• Familiarity with health authority procedures and guidance for electronic submissions.
• Knowledge of Electronic Document Management Systems.
• Ability to manage multiple tasks effectively to meet priorities and deadlines.
• Self-starter with strong time management skills, capable of working independently and collaboratively.
• Excellent attention to detail.
• Strong oral and written communication skills.
• Submission management skills are a plus.

About You

You are passionate about our purpose, bring precision and excellence to your work, and believe in a science-rooted approach to problem-solving. You are a generous collaborator, comfortable working with diverse teams, and take pride in enabling the success of others. You are innovative, can navigate ambiguity, and thrive in a dynamic environment.

About Genmab

Genmab is an international biotechnology company headquartered in Copenhagen, Denmark, with a global presence. We are committed to transforming the lives of patients with cancer and other serious diseases through our innovative antibody therapeutics. Our team is driven by a shared purpose to create, champion, and maintain a global workplace where unique contributions are valued, fostering innovative solutions to meet patient needs.

Location

This is an onsite position in Denmark.

Genmab embraces an agile working environment to enhance employee work-life balance. Our offices are designed as open, community-based spaces that foster connection and collaboration.