Regulatory Professional
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Søborg
Do you want to play a key role in accelerating the development of our patient-focused products? Are you passionate about regulatory science and executing on regulatory strategies to bring innovative medicines to patients? If so, we invite you to become a part of our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who play pivotal roles in developing medical solutions and obtaining approvals from regulatory authorities worldwide. Apply now and join us in this exciting journey! Position As a Regulatory Professional collaborate closely with the Global Regulatory Lead and a team of regulatory professionals, working together to advance projects across all development phases within the Semaglutide diabetes portfolio. Your key responsibilities will be focused on: Become a member of cross functional project teams including study groups and submission teams and provide regulatory input within the Semaglutide department 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, working with affiliates to ensure alignment between local and global regulatory strategies and timely preparation of documentation Interact with stakeholders across various departments, including project management, medical and non-medical specialists, statisticians, and medical writers providing regulatory input and contributing to project decisions 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. We embrace the hybrid workplace – with a blend of on-site office-based work in Søborg, Denmark where our team is based and home office in Denmark. You will report to the Team Leader of RA Semaglutide Diabetes 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 with the ability to 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 an ideal candidate to have the following: Bachelor´s degree, master’s degree, or Ph.D. in science, pharmaceutical or health science Minimum 2 years of experience in Regulatory Affairs or other relevant area in drug development Experience using MS Office tools; knowledge of Veeva Vault Rim would be an advantage Ability to communicate in fluent English (both written and spoken) 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 The RA Semaglutide Diabetes department is responsible for defining and implementing regulatory strategies for Semaglutide projects in the diabetes therapeutic area across all development phases. We are 10 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Georgina Hrobak - Regulatory Affairs Team Leader, at +45 30 75 50 38.
Deadline 10th March 2024 Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible. 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.
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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Georgina Hrobak - Regulatory Affairs Team Leader, at +45 30 75 50 38.
Deadline 10th March 2024 Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible. 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 "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 1.3.2024, 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.
- Apoteker
- Søborg
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Statistik over udbudte apotekere i Søborg over tid
| Dato | Alle jobs som apotekere |
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| 26. november 2024 | 1 |
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| 27. oktober 2024 | 3 |