Senior Regulatory Professional
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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. Apply today and join us for a life-changing career!
The position
As Senior Regulatory Professional, you will take part in developing regulatory strategies and lead execution via interactions with cross-functional teams. In this role, you will be responsible to lead the development of a new indication within one of NN approved products. Your main responsibilities will include the following: Become a member of cross functional project teams including study groups and submission teams and contribute to global regulatory strategies and tactics by providing your specialist knowledge via analyzing regulatory opportunities and risks Drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines Leading major submission tracks such as 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 Driving global roll-out and submission plans Interact with stakeholders across various departments, such as project management, medical and non-medical specialists, statisticians, and medical writers
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 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 you to have: Master’s degree or Ph.D. in science, pharmaceutical or health science Minimum 5 years of experience in the pharmaceutical industry Solid and hands-on regulatory experience Ability to communicate in fluent English (both written and spoken)
On a personal level you: Bring a can-do attitude and demonstrate a flexible, change-oriented approach Demonstrate proactivity and employ excellent project management skills Have a willingness to experiment and a tendency to view challenging situations as opportunities rather than limitations. 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 20 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 Georgina Hrobak at +45 30 75 50 38.
Deadline
13 June 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.
The position
As Senior Regulatory Professional, you will take part in developing regulatory strategies and lead execution via interactions with cross-functional teams. In this role, you will be responsible to lead the development of a new indication within one of NN approved products. Your main responsibilities will include the following:
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 you to have:
On a personal level you:
RA Semaglutide II is responsible for defining and driving regulatory strategies for our Semaglutide projects in all phases of development. We are 20 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 Georgina Hrobak at +45 30 75 50 38.
Deadline
13 June 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 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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