Global Regulatory Affairs Expert, Transformation Project
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Søborg
Would you like to play a role in one of the biggest transformation projects underway in the Novo Nordisk Development organization? Are you motivated by the opportunity to make a meaningful impact on the lives of millions of people in need of Novo Nordisk’s new life-changing treatments? We are now searching for 2 Regulatory Experts be part of a Matrix team within Global Regulatory Affairs (GRA) that will expand and accelerate the Fit4Take-off Label and submission engine to support our transformation journey. If it sounds interesting for you, then this is your chance to join us. Apply now!
The position Nearly 2 years ago, we launched Fit4Take-off (F4TO)- a ‘Moonshot’ aspiration to be ready for submission of new drugs to medical authorities just 4 days after Last Patient Last Visit in clinical trials: in our 4 most important markets AND secure launch only 4 days after approval. The Fit4Take-off programme is now a highly visible and recognised transformation programme, with a clear purpose to bring innovative treatments faster to our patients. The “Label Submission engine” is anchored in Global Regulatory Affairs and drives changes in mindset, processes and digitalisation. As a representative of Regulatory Affairs, you will be perceived as a valued business partner across the organisation, and you will join a fun, supportive, and inclusive work environment. In this position your responsibilities will be: The driver to transform processes, digitalise and change mindset Creating initiatives to optimise and accelerate the way we create labelling, and plans submissions Part of a F4TO matrix team lead by a project manager. This team will have responsibility for deliverables within the Label & Submission engine. The team will secure learnings and increase collaboration across RA areas and be able to move at a fast pace Interacting with engine leads, business owners and leaders of the drug projects, you will be involved in bringing forward new ideas, testing ideas and the importantly subsequent anchoring these transformations in the organisation The positions will be anchored in Line of Business and report to either Senior director of RA Diabetes and Obesity or Senior director of RA Cardiovascular Disease and Chronic Kidney Disease. Qualifications As an ideal candidate, you have: Strong background in Regulatory Affairs (RA) and/or drug development Relevant Master’s degree Very solid process experience and Subject Matter Expert (SME) knowledge for RA processes including labelling, clinical development Digital mindset and strong IT skills Good communication skills and fluency in written and spoken English Ability to manage and prioritize tasks and projects It would be considered as an advantage to have a design thinking mindset. On a personal level, you have a high level of drive and result-orientation while being a team player. You are curious and innovative by nature and like to be challenged. You thrive in agile and matrix set-up’s and are comfortable interacting with stakeholders at different organisational levels. About the department In Regulatory Affairs Therapeutic Areas (TAs) we are responsible for leading the regulatory science and designing the global regulatory strategies to advance projects from early stages of research and development to worldwide submission and approval of initial Marketing Authorisation applications. We work as an integrated part of the Novo Nordisk Development organisation. We are responsible for the development, implementation and execution of global regulatory strategies and regulatory operational activities fully integrating pivotal elements of data, digital health, devices and diagnostics. We drive label development, health authority interactions and regulatory submissions. Each team include around 10 highly skilled and engaged team players with diverse backgrounds. In Novo Nordisk Global Regulatory Affairs, we are committed to being one step ahead. The robust strategies we build, prepare, and execute are based on our work across the entire product development value chain. As we are involved from the earliest research and all the way to securing and maintaining commercial licenses for our medicines, we feel like the glue that connects everything. We strive to make our work and efforts valuable and impactful to both Novo Nordisk and the lives of our patients. All for the purpose of driving change and giving people access to best-in-class, life-changing treatments – faster than ever. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re in-spired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific re-search, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact
For further information, please contact David Truloff +45 3079 0499 or Poul-Martin Haahr +45 3075 4082 Deadline 13 February 2023. Applications will be reviewed continuously when received and candidates may be called for interview before the deadline. We are looking for several similar profiles at Novo Nordisk now. Therefore, Hiring Managers from different teams might also look at your application. 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.
The position Nearly 2 years ago, we launched Fit4Take-off (F4TO)- a ‘Moonshot’ aspiration to be ready for submission of new drugs to medical authorities just 4 days after Last Patient Last Visit in clinical trials: in our 4 most important markets AND secure launch only 4 days after approval. The Fit4Take-off programme is now a highly visible and recognised transformation programme, with a clear purpose to bring innovative treatments faster to our patients. The “Label Submission engine” is anchored in Global Regulatory Affairs and drives changes in mindset, processes and digitalisation. As a representative of Regulatory Affairs, you will be perceived as a valued business partner across the organisation, and you will join a fun, supportive, and inclusive work environment. In this position your responsibilities will be:
Contact
For further information, please contact David Truloff +45 3079 0499 or Poul-Martin Haahr +45 3075 4082 Deadline 13 February 2023. Applications will be reviewed continuously when received and candidates may be called for interview before the deadline. We are looking for several similar profiles at Novo Nordisk now. Therefore, Hiring Managers from different teams might also look at your application. 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 11.1.2023, 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
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