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Senior Manager, Global Regulatory Operations, Publisher

CompraTica Empleos

EMP:Administration
Denmark
Tiempo Completo
Remoto
1 vistas

Descripción

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! 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.

Responsabilidades

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 revi.

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