Regulatory Professional - Submission Management, Global Regulatory Affairs

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Søborg

Would you like to join Submission Management, Global Regulatory Affairs and become part of an exciting environment where engaged people work with new technologies and diverse therapeutic areas to bring innovative medicines to patients? Do you want to manage major global eCTD submission projects and support the integration and continuation of eCTD submissions of newly acquired products and submission projects in connection with Novo Nordisk acquisitions? Apply today and join us for a life-changing career. The position Your main task will be to manage and publish major global eCTD submission projects in cooperation with the regulatory teams, the report publishing units, and the global regulatory publishing team. In addition, you will also be managing and publishing roll-out and lifecycle eCTD submissions and contribute to our continuous improvement of our publishing processes and support to our colleagues and stakeholders. Finally, a key task will be to support the integration and continuation of eCTD submissions of newly acquired products and submission projects in connection with Novo Nordisk acquisitions. You have a good understanding of the evolving eSubmission standards, and will ensure that we always deliver efficient, timely and compliant submissions to the regulatory agencies. You will work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration, and the challenges of international communication will be part of your busy workday. You will be expected to make an impact, to ask questions, and to challenge the status quo to ensure continuous improvements, visionary systems, and services. Qualifications To succeed in this role, we expect you to have:
  • A master’s degree preferably within life sciences
  • 3-5 years of relevant working experience preferably within Regulatory Operations or Regulatory Affairs
  • Strong interest in and knowledge about eCTD publishing processes and document management
  • Good project management skills and strong in setting direction and making impact
  • Strong written and verbal communication skills in English
    • As a person you are a team player who maintains customer focus even when delivering submissions under sometimes tough circumstances. You are open to flexible working hours to accommodate other time zones when needed. You are well organised, analytical with solid problem-solving capabilities, just as you show a winning and positive attitude, and never lose your strategic focus. You can keep your spirits high even under pressure, and as a skilled communicator you can cooperate at any organisational level. About the department You will join the Submission Management department to support both the growing number of global electronic submissions in Novo Nordisk and to ensure a robust and visionary design of our processes and submission related activities. In Submission Management, you will be interacting with many stakeholders in the company in relation to managing, publishing, and delivering eCTD submissions, and other submission types. Furthermore, you will participate in projects, where you will be involved in establishing future work processes and improvements for handling of submissions. The Submission Management department is situated in Søborg, Denmark. We work with submission management and publishing to health authorities worldwide. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without letting perfection standing in the way of good. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Robert Navy Lund at +45 3079 9943. Deadline 16 March. We shall conduct interviews on an ongoing basis, so please submit your application as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 7.2.2023, men kan have været deaktiveret og genaktiveret igen.

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    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Øvrige
    • Søborg
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