Senior Regulatory 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? Would y ou like to become part of an exciting environment, where engaged people are committed to gaining approval of Novo Nordisk’s medicines by regulatory authorities across the globe? If you do, then join as a Senior Regulatory Professional in the Regulatory Affairs (RA) team. We are expanding the team and have several open positions, where you get to work with dedicated colleagues on many exciting projects, who work to bring innovative treatment to patients across the globe – faster than ever. Apply now! The position As Senior Regulatory Professional, you will take part in developing regulatory strategies and lead their execution via interactions with cross-functional teams. We have vacant positions within two therapeutic areas: Cardiovascular Diseases and Diabetes & Obesity (please note in your CV/Cover Letter if you have a specific preference). In your job you will be involved in strategic regulatory activities including: Contributing to global regulatory strategies and tactics by providing your specialist knowledge via analysing regulatory opportunities and risks Ensuring that the project strategy is implemented in clinical trial protocols and documents supporting clinical trial applications Taking lead on preparation of briefing packages for interactions with Health Authorities globally Taking lead in development of global label claims and translating the claims to local label text for submissions in target countries You will also be responsible for tactical actions ensuring execution according to the regulatory strategies, this will include: Ensuring timely submission of clinical trial applications to progress the clinical programme Taking lead on major submission tracks as submission country lead, where you will be working with stakeholders in affiliates to ensure alignment between local and global regulatory strategies and timely preparation of regulatory documentation Your regulatory role will require being proactive and bold, challenging the discussions and contributing to project team decisions. You will collaborate with Project Management, Medical and Non-clinical Specialists, Statisticians, and Medical Writers. You will be part of regulatory matrix team driven by a Global Regulatory Lead, where you will collaborate together with regulatory colleagues from CMC (Chemistry, Manufacturing and Control), device and digital areas. In this role, your 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. 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 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 departments 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 and as an integrated part of the development and research cross-functional project teams. We are looking for Senior Regulatory Professionals to engage in crucial activities on projects in late phase of development approaching the exciting phase of the clinical programme read-out and for new drug submissions worldwide. RA Cardiovascular & Chronic Kidney Disease is responsible for 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 investigate 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 are looking for a Senior Regulatory Professional who will focus on a late-stage clinical development asset with ongoing activities in 3 different indications. 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 Magdalena Jayatissa at [email protected] or +45 3079 4942 or Poul-Martin Haahr at +45 3075 4082. Deadline 5 April 2023. Interviews will be conducted on an ongoing basis, so we encourage you to apply as soon as possible. Please note that as we are hiring for several positions at the moment, managers from different departments will have access to 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 16.3.2023, 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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