Senior Manager, Global Regulatory Operations, Publisher

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

Genmab is seeking a motivated individual to join a team committed to delivering quality submissions. A Senior Manager is responsible for activities related to regulatory publishing and submission management support to FDA EMA MHRA SwissMedic and more. Seeks to contribute into innovation process while supporting GRA strategy and deliverables. Supports activities to implement new technology solutions in support of regulatory publishing business process.

Responsibilities

• Responsible for the creation assembly and publishing of both 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 etc.) and lifecycle management while clearly communicating regional regulatory differences.
• Perform QC and technical validation of electronic submissions to ensure compliance with internal standards and external criteria before delivery to the Regulatory Users for internal review/approval.
• Adherence to required submission timelines health authority publishing specifications and internal working practices.
• Liaise with functional source areas (clinical nonclinical regulatory) to ensure documents are compliant with authoring style guide. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the 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 pharmaceutical industry experience and prior Regulatory Operations experience required.
• Knowledge of IND BLA MAAregarding CTD requirements and guidelines for both eCTD and NeeS.
• Knowledge of industry trends regarding electronic submissions.
• Technical knowledge of electronic publishing systems and software.
• Proficiency with MS-Office Suite and Adobe Acrobat application.
• Knowledge of health authority procedures/guidances 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 and ability to work independently or in teams.
• Strong attention to detail.
• Strong communication skills - both oral and written
• Nice to have submission management skills.

The proposed gross annual base salary range for this position in the primary location based on a full time schedule is:

The final salary offer will depend on several factors including your skills qualifications and experience.

In addition to base salary this position is eligible to additional forms of compensation such as discretionary bonuses and long-term incentives.

When you join Genmab you become a part of a culture that supports your physical financial social and emotional well-being. Our benefits include but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on compensation and benefits will be provided during the recruitment process.

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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