Senior Regulatory Professional
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Søborg
Would you like to be part of a team working on a project in phase 3 within a rare disease that soon will face an exciting period of authority interactions and planning for marketing authorisation on a global scale? Do you want to be responsible for driving several regulatory tasks in a cross functional project and submission team and to interact with a variety of stakeholders in Novo Nordisk. Apply today and join us in Regulatory Affairs in Søborg for a life-changing career. The position As our new Senior Regulatory Professional, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. You will be a member of cross functional project and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk such as project management, medical and non-clinical specialists, statisticians, and medical writers. Among other things, you will be responsible for the development of regulatory documentation for submission to Health Authorities including response packages, clinical trial applications, paediatric investigation plans, labelling, and regulatory files for marketing authorisation. Specifically for this job, you will get the opportunity to be part of a team working on a project in phase 3 within a rare disease that soon will be facing a very exciting period of authority interactions and planning for marketing authorisation. You will report to the Associate Director of RA or Haemoglobinopathies and Early Development and take active part in department-related activities, including improvement projects across RA. Qualifications To succeed in this role, we expect you to have a university degree in life science and 4-5 years of regulatory or drug development experience. As a person you thrive in a fast-paced work environment with unfamiliar situations. You bring a can-do spirit and are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. You are a skilled communicator who can collaborate as a strategic business partner at any organizational level. Finally, you are comfortable using your fluent written and spoken English. About the department In Regulatory Affairs (RA) Haemoglobinopathies and Early Development we contribute to the development of treatments within Rare Blood Disorders with a pipeline including a variety of different modalities and technologies. We are a team of 7 dedicated and highly engaged employees with diverse background and experience. We value trust & openness and work in an environment where sharing of knowledge, new ideas, and innovative approaches to regulatory strategy and tactics are highly appreciated. We are an integrated part of the global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and tactics and provide regulatory expertise to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications. We have a strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams with colleagues from RA CMC, RA device, US etc., who all have important roles and contributions, and together form a team with the capacity to execute ambitions plans. 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 Marie Aavang Geist at +45 3448 0290. Deadline 12 March 2023. 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.
Information og data
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 20.2.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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| Dato | Alle jobs som øvrige |
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| 21. november 2024 | 63 |
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| 25. oktober 2024 | 52 |
| 24. oktober 2024 | 56 |