Global Regulatory Lead / Senior Regulatory Affairs Professional

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Søborg

Do you want to have a direct impact on developing life-changing and best-in class solutions for our patients within cardio-vascular diseases? Are you able to cut through complexity and drive regulatory strategies for high impact projects? If you do, then join our Regulatory Affairs (RA) team within cardiovascular and chronic kidney diseases and become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s medicines to bring innovative treatment to patients across the globe – faster than ever. We are expanding the team, therefore we currently have openings for 2 positions, namely a Global Regulatory Lead and a Senior Regulatory Affairs Professional. Apply now! The positions As Global Regulatory Lead you will be responsible for developing regulatory strategies and executing several regulatory tasks with challenging and often overlapping timelines. You will be a member of cross functional project teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk. You will lead RA matrix teams and represent RA towards our internal and external stakeholders. Focus will be on different early-stage projects within cardio-vascular and renal diseases. As Regulatory Affairs Professional, you will support the development of regulatory strategies and execute regulatory tasks in cross functional project teams, and thereby, interact with many of stakeholders. Focus will be on a late-stage clinical development asset with ongoing activities in 3 different indications. Your tasks in both roles will include the following:
  • Promote and develop the global regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to project team decisions
  • Develop regulatory documentation for submission to Health Authorities including meeting briefing packages, clinical trial applications, regulatory file for marketing authorisation and response packages for Health Authorities
  • Interact with project management, medical and non-clinical specialists, statisticians, and medical writers
    • You will report to the Senior Director of RA CVD-CKD (cardio-vascular and chronic kidney diseases) and take active part in department related activities, including improvement projects across RA and work closely with affiliates around the world. Qualifications As an ideal candidate you have:
  • An academic degree in life science or similar, may be supplemented with a PhD degree
  • Several years of regulatory or drug development experience preferably from the pharmaceutical industry or from a Health Authority
  • Strong IT/digital skills
  • Fluent written and spoken English
    • As a person, you thrive in a fast-paced work environment characterized by ambiguity. You bring a can-do spirit and a healthy sense of humor to your work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. It is important for you to feel that you are part of a team and an active contributor to the success of the team. You are a skilled communicator who can collaborate as a strategic business partner at any organizational level. About the department RA CVD-CKD department is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within the cardio-vascular and chronic kidney diseases field working with a pipeline including early and late phase projects that investigates a variety of different modalities and technologies including monoclonal antibodies and oral administered peptides. Our department is made up of 11 dedicated and highly engaged employees with diverse background and experience. We work as an integrated part of global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies, provide regulatory expertise and tactics to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications. Our work is essential to keep bringing innovative, patient-centric, and best-in class solutions to our patients. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people. Working at Novo Nordisk At Novo Nordisk, we do not wait for change. We drive it. We are 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 fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we are all working to move the needle on patient care. Contact For further information, please contact Poul-Martin Haahr at +45 3075 4082. Deadline 24 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 6.2.2023, 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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