Senior Regulatory Professional, Late Stage Development

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Søborg

Would you like to become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk’s medicines by regulatory authorities across the globe? Do you have an interest to work with a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders? If yes, you might be the new Senior Regulatory Professional we are looking for to become part of our Regulatory Affairs (RA) Diabetes & Obesity II unit and join to a late-stage project in exciting phase of preparation to initial regulatory submissions and approvals world-wide. Apply now! The position You will drive several regulatory tasks with challenging and often overlapping timelines. Besides, you will be a member of cross functional project teams including study groups and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk. In this position your responsibilities will be :
  • Developing regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports and regulatory file for marketing authorisation.
  • Contributing to the global regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to project team decisions.
  • Interacting with project management, medical and non-clinical specialists, statisticians and medical writers
  • Collaborating closely with Novo Nordisk affiliates worldwide to ensure their strategic input to submission documents and develop timelines for local submissions and approvals of our products
  • Playing a role in projects for the improvement and maintenance of regulatory processes across the organisation
    • Qualifications As an ideal candidate you have:
  • A Master`s degree and /or PhD in life sciences
  • 5-7 years of relevant working experience in regulatory sciences or clinical and non-clinical drug development, medical writing, clinical trial management
    • On a personal level you thrive in a busy environment; bring a can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You are a flexible and change-oriented person who focuses on opportunities rather than limitations in demanding situations. Besides, you are a confident and proactive communicator who has the courage to use their strategic mindset to resolve challenges. About the department RA Diabetes & Obesity II is responsible for the regulatory deliverables for projects in early and late phase of development. We are currently 15 professionals working closely together on our project and our department activities. We work as an integrated part of the development and research cross-functional project teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plans. We drive label development, Health Authority interactions and clinical trial applications. We closely collaborate with our affiliates to prepare and execute on strategies ensuring our novel medicines to enter the markets worldwide. Working at Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Magdalena Jayatissa at + 45 30 79 49 42 Deadline 19 February, 2023 Interviews will be conducted on an ongoing basis, so we encourage you to apply 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 3.2.2023, 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.
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    • Søborg
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