Regulatory Professional

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Søborg

Join Global Regulatory Affairs and become part of a dynamic and exciting organisation where engaged people are committed to obtain Marketing Authorisations for Novo Nordisk’s innovative medicines by regulatory authorities across the globe. We have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work. The job As a Senior Regulatory Professional, you will be required to drive and coordinate several regulatory activities with challenging and often overlapping timelines. 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. You will participate in the development of 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 files for marketing authorisation. Furthermore, you will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions. You will among others interact with medical and non-clinical specialists, statisticians, and medical writers. You will report to the Senior Director of RA Diabetes & Obesity and take active part in department related activities, including improvement projects across RA. Your qualifications
  • We expect you to have a university degree in life science and 1-4 years of Regulatory Affairs experience or other relevant drug development experience.
    • As a person you are a team player, well organised and have solid problem-solving capabilities, just as you show a can-do attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can cooperate at any organisational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis. About the department Regulatory Affairs Diabetes & Obesity is responsible for the development of global regulatory strategies to advance the project within multiple indications from early stages of development to worldwide submission and approvals of initial Marketing Authorisation applications. We work as an integrated part of the global development organisation and play a key role in the cross-functional teams. We are responsible for the development, implementation and execution of global regulatory strategies and regulatory operational activities in alignment with the global project development plan. We drive label development, health authority interactions and regulatory submissions, hereunder initial marketing authorisation applications, paediatric plans, and clinical trial applications. We have a close collaboration with our affiliates and global stakeholders. Regulatory Affairs Diabetes & Obesity currently consists of 17 dedicated and highly engaged employees. The team is expanding as the project progress into multiple indications, late-stage development and submission, and thus we are looking for a new colleague with a strong scientific background combined with regulatory affairs experience to take on the role as Senior Regulatory Professional and be part of the RA team for one of our high priority late-stage development projects. Working at Novo Nordisk At Novo Nordisk, we use our skills, dedication, and ambition to help people with chronic diseases such as Diabetes, Obesity, NASH, CVD, Rare Endocrine Disorders as well as Rare Blood Disorders. We offer the chance to be part of a truly global and highly diverse workplace, where passion and engagement are met with opportunities for professional and personal development. Contact For further information, please contact Eva Thomsen at +45 3075 0253. Deadline 10 April 2023 Please note, we will invite candidates for interviews on an ongoing basis and conclude the recruitment process when the right candidate has been found. 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 14.3.2023, 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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