Regulatory Professional - RA Semaglutide Research & Development
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Søborg
Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s medicines with regulatory authorities across the globe. Our people 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 position(s)
We offer an opportunity for you to kick-start your career within Regulatory Affairs and learn from fantastic colleagues across disciplines and portfolio areas. As a Regulatory Professional, your main responsibilities will include the following:
• Become a member of cross functional project teams including study groups and submission teams and provide regulatory input, challenge the discussion, and contribute to project team decisions.
• Drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines.
• 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 authorization.
• Interact with medical and non-clinical specialists, statisticians, and medical writers. Furthermore, you will work in a fast-paced environment with tight deadlines and deal with the challenging reality of international communication across time zones, cultures, and circumstances. The atmosphere is informal and good humor is always welcome. You will report to the Team Leader of RA Semaglutide II and take active part in department related activities, including improvement projects across RA.
Qualifications
We are looking for a person who is comfortable speaking their mind, enjoys a challenging problem and has a strong personal drive. You can keep your spirit high under pressure. You have a professional and personal impact that is reflected in your desire to take initiative and finally, you must have a willingness to take responsibility for your own learning. We expect you to have:
• Bachelor’s degree or Master’s degree in life science
• Regulatory affairs experience or other relevant drug development experience
• 1-3 years of work experience in relevant RA will be an added advantage On a personal level you: • Are curious to learn, proactive and solution oriented
• Have a can-do attitude and never lose your strategic focus
• Challenge the discussions and contribute to project team decisions for the project you work with
• Are a skilled communicator who can cooperate at any organizational level
• Bring a positive attitude and are self-motivated About the department
RA Semaglutide II is responsible for defining and driving regulatory strategies for our Semaglutide projects in all phases of development. We are 19 dedicated and highly engaged employees in the department belonging to the RA Semaglutide area. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams.
We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plans. We drive label development, health authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams. 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 either Georgina Hrobak at +45 30 75 50 38 or Signe Zaar Grønlund at +45 30 75 49 43. Deadline
9th May 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 submit an English version of your resume and include a few sentences about your motivation towards this position. 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(s)
We offer an opportunity for you to kick-start your career within Regulatory Affairs and learn from fantastic colleagues across disciplines and portfolio areas. As a Regulatory Professional, your main responsibilities will include the following:
• Become a member of cross functional project teams including study groups and submission teams and provide regulatory input, challenge the discussion, and contribute to project team decisions.
• Drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines.
• 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 authorization.
• Interact with medical and non-clinical specialists, statisticians, and medical writers. Furthermore, you will work in a fast-paced environment with tight deadlines and deal with the challenging reality of international communication across time zones, cultures, and circumstances. The atmosphere is informal and good humor is always welcome. You will report to the Team Leader of RA Semaglutide II and take active part in department related activities, including improvement projects across RA.
Qualifications
We are looking for a person who is comfortable speaking their mind, enjoys a challenging problem and has a strong personal drive. You can keep your spirit high under pressure. You have a professional and personal impact that is reflected in your desire to take initiative and finally, you must have a willingness to take responsibility for your own learning. We expect you to have:
• Bachelor’s degree or Master’s degree in life science
• Regulatory affairs experience or other relevant drug development experience
• 1-3 years of work experience in relevant RA will be an added advantage On a personal level you: • Are curious to learn, proactive and solution oriented
• Have a can-do attitude and never lose your strategic focus
• Challenge the discussions and contribute to project team decisions for the project you work with
• Are a skilled communicator who can cooperate at any organizational level
• Bring a positive attitude and are self-motivated About the department
RA Semaglutide II is responsible for defining and driving regulatory strategies for our Semaglutide projects in all phases of development. We are 19 dedicated and highly engaged employees in the department belonging to the RA Semaglutide area. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams.
We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plans. We drive label development, health authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams. 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 either Georgina Hrobak at +45 30 75 50 38 or Signe Zaar Grønlund at +45 30 75 49 43. Deadline
9th May 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 submit an English version of your resume and include a few sentences about your motivation towards this position. 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 19.4.2023, 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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