Early Development Regulatory Affairs Expert
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Søborg
Are you passionate about science and want to work with early development projects? Do you dream about doing science for the people and work for a cause? Do you want to directly impact the projects with your scientific knowledge and set the regulatory direction? Then we have what you have been looking for in Regulatory Affairs (RA) CMC (Chemical, Manufacture and Control), Diabetes & Obesity. Apply now for our Early Development Regulatory Affairs Expert role! The Position We are looking for a colleague with a scientific background in early research of drug development to work with the earliest stages of diabetes and obesity drug development in Regulatory Affairs CMC. In this position we guarantee that you will feel that your work has an impact. You will be the voice of Regulatory Affairs CMC. Your responsibilities will consist of: Providing scientific and strategic input to the projects to obtain the regulatory approvals Turning scientific knowledge into regulatory pathways and develop global regulatory CMC strategies based on current legislation and regulations Project planning, coordinating, and reviewing regulatory documentation related to the drug e.g., supporting preparation of applicable sections of submission packages, responses to agency questions for global markets and Agency Meeting Packages This role offers an opportunity for you to continue your individual development and connect your scientific knowledge to the regulatory framework of CMC in benefit of the patients. You will work in a fast-paced environment with tight deadlines and work closely together with colleagues across time zones and cultures. The atmosphere is informal and good humour is always welcome. Our commitment to innovation also applies to the way we work - we embrace a flexible workplace, with a blend of in-office and remote work. Qualifications As an ideal candidate, you: Have a Master’s degree or Ph.D. in science, pharmaceutical science, engineering, or another relevant academic field Have +5 years of experience working within research and drug development in the pharmaceutical industry Experience with Regulatory Affairs and/or project management will be an advantage but not a requirement Fluent written and spoken English On a personal level, you are curious to learn, self-motivated, proactive and solution oriented. You have a strategic mindset and the ability to set direction for your projects. Challenging discussions and contributing to project team decisions for the project you work with is also important. You need to have great communication skills and the ability to communicate scientifically difficult topics, so it is easily understood by different kinds of stakeholders. About the department RA CMC Diabetes & Obesity is part of Global Regulatory Affairs and consists of 45 colleagues working in different project teams from early phases of drug development throughout the life cycle of the marketed products worldwide. We are responsible for driving the RA CMC strategy and submission activities related to the drug of the drug-device development projects and the oral development projects. 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 Jeppe Engelheim Müggler (+45 3075 6025) or Samantha Donslund Schwab (+45 3079 4018). Deadline
16 April 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. 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.
For further information please contact Jeppe Engelheim Müggler (+45 3075 6025) or Samantha Donslund Schwab (+45 3079 4018). Deadline
16 April 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. 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 30.3.2023, 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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