Senior Regulatory Affairs Professional
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Søborg
Do you dream of a career with a global pharmaceutical company built on life-changing innovations? Do you want to work with regulations of innovative investigational medicines and devices? Does working with highly talented and engaged colleagues from many different professional backgrounds and cultures inspire you?
If yes, join us as a Senior Regulatory Affairs Professional in the RA Device Execution Team.
About the department
In the RA Device Execution team, we are responsible for supporting the RA strategy and submission activities for the device constituent of a drug-device development project to obtain approvals for our new innovative biologic and drug-device combination projects globally.
We are responsible for planning and implementing strategies for our CE-marked devices based on current legislation and regulations and negotiating with authorities to ensure minimum time to market. RA Device process-related work is also part of the department.
RA Device Execution Team is part of the RA CMC(Chemistry, Manufacturing and Control) & Device Area.
RA is a truly multi-disciplinary department with high professional standards and excellent opportunities for fast-paced professional development and career progression.
The position
Novo Nordisk is evolving its portfolio in drug-device combination product development and CE-marked devices across an exciting array of innovative products, including biopharmaceuticals and new delivery systems.
As a Senior Regulatory Affairs Professional in our area, you will be working closely with colleagues across the organization and leading key activities from early development through to clinical trials and up to marketing applications. Your other responsibilities include:
You will get a unique opportunity to establish a global network and to enhance your knowledge by participating in innovative projects involving highly skilled people – all experts within their field. Furthermore, you will get the opportunity to participate in advocacy groups both internally and externally in close collaboration with our RA Policy & Intelligence group. Most importantly, you will have the possibility to influence your role according to your interests and specialization.
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 humour is always welcome. Our commitment to innovation also applies to the way we work: We embrace a hybrid workplace, with a blend of in-office and remote work.
Qualifications
As an ideal candidate, you have:
As a person, it is imperative that you are self-driven, have a strategic mindset, and are able to make the right regulatory decisions – and thus drive the regulatory agenda. With a proactive and innovative approach, you are able to bring valuable input and set the strategic direction for the project(s). Finally, you can communicate complex regulatory topics to many different stakeholders from R&D to production and marketing.
At Novo Nordisk, your skills, dedication, and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive change. 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. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better of millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life-changing.
Contact
For further information please contact Associate Director Lena Høvring von Grumbckow (+45 30795342).
Deadline
Applications will be evaluated continuously when received and candidates may be called for an interview before the deadline.
To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.
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If yes, join us as a Senior Regulatory Affairs Professional in the RA Device Execution Team.
About the department
In the RA Device Execution team, we are responsible for supporting the RA strategy and submission activities for the device constituent of a drug-device development project to obtain approvals for our new innovative biologic and drug-device combination projects globally.
We are responsible for planning and implementing strategies for our CE-marked devices based on current legislation and regulations and negotiating with authorities to ensure minimum time to market. RA Device process-related work is also part of the department.
RA Device Execution Team is part of the RA CMC(Chemistry, Manufacturing and Control) & Device Area.
RA is a truly multi-disciplinary department with high professional standards and excellent opportunities for fast-paced professional development and career progression.
The position
Novo Nordisk is evolving its portfolio in drug-device combination product development and CE-marked devices across an exciting array of innovative products, including biopharmaceuticals and new delivery systems.
As a Senior Regulatory Affairs Professional in our area, you will be working closely with colleagues across the organization and leading key activities from early development through to clinical trials and up to marketing applications. Your other responsibilities include:
- Interaction with health authorities
- Submission of regulatory files to ensure product approval. Your regulatory expertise is needed to
- Determine the regulatory strategy
- Support the projects as well as the affiliates.
- Drive and support some of our regulatory device processes.
You will get a unique opportunity to establish a global network and to enhance your knowledge by participating in innovative projects involving highly skilled people – all experts within their field. Furthermore, you will get the opportunity to participate in advocacy groups both internally and externally in close collaboration with our RA Policy & Intelligence group. Most importantly, you will have the possibility to influence your role according to your interests and specialization.
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 humour is always welcome. Our commitment to innovation also applies to the way we work: We embrace a hybrid workplace, with a blend of in-office and remote work.
Qualifications
As an ideal candidate, you have:
- Master’s degree in Science, Engineering, Pharmacy, or other relevant education
- Minimum 5 years of relevant experience working with regulations of medical devices and/or combination products.
- Knowledge of international legislation and standards, and experience in the pharmaceutical industry, as well as project management, will be an advantage.
- Fluency in written and spoken English
- Strong communication skills and you bring a can-do attitude.
As a person, it is imperative that you are self-driven, have a strategic mindset, and are able to make the right regulatory decisions – and thus drive the regulatory agenda. With a proactive and innovative approach, you are able to bring valuable input and set the strategic direction for the project(s). Finally, you can communicate complex regulatory topics to many different stakeholders from R&D to production and marketing.
At Novo Nordisk, your skills, dedication, and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive change. 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. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better of millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life-changing.
Contact
For further information please contact Associate Director Lena Høvring von Grumbckow (+45 30795342).
Deadline
Applications will be evaluated continuously when received and candidates may be called for an interview before the deadline.
To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.
Print job Send to e-mail
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 30.8.2022, 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
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