Global Regulatory Specialist, RA Semaglutide
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Søborg
We are currently looking for a Global Regulatory Specialist with a strong scientific background and a genuine interest in being part of Regulatory Affairs (RA), Semaglutide. Join RA and become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s 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 amazing job opportunity! The position
In this position, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. Your focus will be to lead development of new oral technologies and platforms applied to peptides. Specifically, you will have a critical responsibility in assessing regulatory pathways for different oral technologies, formulation concepts, support innovative trial designs and responding to major Health Authorities' queries to secure progress toward regulatory approvals. It will be expected from you to: Be involved in critical strategic discussions within the project, where you will be expected to contribute to regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to business-critical decisions Share your knowledge and experience with more junior colleagues, help them develop, and support the regulatory project team's high performance Interact with project management, medical and non-clinical specialists, statisticians, medical writers, and subject matter experts Contribute to projects for the improvement and maintenance of regulatory processes across the organisation Qualifications
We expect you to have the following: Master of Science degree (life sciences) with 6-8 years relevant experience and/or PhD with 4-5 years of relevant working experience Solid knowledge of handling regulatory documentation for pharmaceutical development within the quality, non-clinical or clinical area Experience interacting directly with regulatory authorities on an international scale Strong negotiation skills and a sound business understanding Fluent written and spoken English
As a person, you are well-organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. While also being a team player who supports colleagues, you must be able to set direction, lead, and inspire your team to work toward shared goals. 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 Thomas Nedergaard Jensen at [email protected].
Deadline 05 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.
In this position, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. Your focus will be to lead development of new oral technologies and platforms applied to peptides. Specifically, you will have a critical responsibility in assessing regulatory pathways for different oral technologies, formulation concepts, support innovative trial designs and responding to major Health Authorities' queries to secure progress toward regulatory approvals. It will be expected from you to:
We expect you to have the following:
As a person, you are well-organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. While also being a team player who supports colleagues, you must be able to set direction, lead, and inspire your team to work toward shared goals. 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 Thomas Nedergaard Jensen at [email protected].
Deadline 05 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 Søborg.
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.
- Øvrige
- Søborg
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