Senior Regulatory Professional, Semaglutide
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Would you like to become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk’s medicines by regulatory authorities across the globe? Do you have a strong scientific background and a genuine interest in being part of Regulatory Affairs (RA)? Then look into our new job opening for Senior Regulatory Professional within Regulatory Affairs, Semaglutide Cardiovascular Outcome Trials (CVOT) Team. 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 and join us! The position As a Senior Regulatory Professional, you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines. You will act as a trusted advisor both internally and externally and take active part in department related activities, including improvement projects across RA. Moreover, there are many opportunities for both professional and personal development in the role. Your responsibilities include: Become 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 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 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 Qualifications We expect you to have: Bachelor’s degree or Master’s degree in pharmaceutical, medical or life science 5 years of experience in Regulatory Affairs or other relevant clinical, medical or drug development experience Fluent written and spoken English As a person, you are well-organised and have solid problem-solving mindset, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. Finally, you are skilled communicator who can work at any organisational level. About the department
RA Semaglutide is responsible for defining and driving regulatory strategies for our Semaglutide projects in all phases of development. We are 30+ dedicated and highly engaged employees in the department belonging to the RA Semaglutide VP area within Global Regulatory Affairs. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams. We manage 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 Emel Mashaki Ceyhan at +45 3448 1007.
Deadline 12 March 2023. 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.
RA Semaglutide is responsible for defining and driving regulatory strategies for our Semaglutide projects in all phases of development. We are 30+ dedicated and highly engaged employees in the department belonging to the RA Semaglutide VP area within Global Regulatory Affairs. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams. We manage 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 Emel Mashaki Ceyhan at +45 3448 1007.
Deadline 12 March 2023. 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 Bagsværd.
Jobbet er oprettet på vores service den 15.2.2023, 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.
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