Senior Regulatory Professional

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Søborg

Join Global Regulatory Affairs (RA) 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. Apply now for this life-changing opportunity and come aboard as Senior Regulatory Professional! The position In this role, 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 report directly to the Senior Director of RA Cagrisema. Your key responsibilities include:
  • 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
  • Provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions
  • Interact with medical and non-clinical specialists, statisticians, and medical writers
  • Take active part in department related activities, including improvement projects across RA
    • Qualifications We expect you to have:
  • University degree in life science or similar
  • At least 5-6 years of Regulatory Affairs or other relevant drug development experience
  • Fluent written and spoken English
    • 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. About the department The Regulatory Affairs Diabetes & Obesity team develops global regulatory strategies for multiple indications, from early development to worldwide submissions and approvals of initial Marketing Authorisation applications. As an integral part of the global development organisation, we play a key role in cross-functional teams. Our responsibilities include developing, implementing, and executing global regulatory strategies aligned with the project development plan, driving label development, health authority interactions, and regulatory submissions, as well as collaborating closely with 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 be part of the RA team for one of our high priority late-stage development projects. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re 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’re all working to move the needle on patient care. 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. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application. 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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