Regulatory Affairs Professionals - RA Device Combination Products
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Søborg
Are you ready to join a company that is leading the way in diabetes care and changing the lives of millions of people around the world? Do you dream of a career with a global pharmaceutical company built on life-changing innovative investigational medicines and devices? Does working with highly talented and engaged colleagues from many different professional backgrounds and cultures inspire you? Then you could be one of our new Regulatory Affairs Professionals in the RA Device Combination Products department. Apply now! The position Novo Nordisk is evolving its portfolio in drug-device combination product development across an exciting array of innovative products, including biopharmaceuticals and new delivery systems. As a Regulatory Affairs Professional in our area, you will be working closely with colleagues across the organisation and supporting activities from early development through to clinical trials and up to Notified Body submission and subsequent marketing applications. Your main responsibilities will include: Be responsible for representing RA Device in the cross-functional RA matrix and device development project teams
Supporting seamless submissions of Clinical Trial Applications and New Drug Applications
Most importantly, you will have the possibility to influence your role according to your interests and specialisation. 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
To succeed in this role you have: A Master’s degree in Science, Engineering, Pharmacy or other relevant education
Experience from the pharmaceutical industry
Preferably have relevant experience working with regulations of combination products and/or medical devices, but it is not required
Excellent planning and coordination skills to handle complex tasks
We are seeking candidates who thrive in a busy environment, bring a can-do attitude, and are comfortable speaking their mind. You can manage multiple project tasks in parallel, exercise sound personal judgement, and possess excellent interpersonal skills. Additionally, we value individuals who enjoy tackling challenging problems, exhibit a strong personal drive, take initiative, and take responsibility for their own learning. Fluency in both oral and written English is a prerequisite.
At Novo Nordisk, your skills, dedication, and ambition help us change patient’s 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. About the department RA Device Combination Products is part of the RA CMC & Device Area in Novo Nordisk. In RA Device Combination Products, we are responsible for submission planning including applying intelligence and develop regulatory strategy for the device constituent of drug-device combination projects, to ensure minimum time to market and thus patients. This includes evaluating applicable guidelines, requirements and using external relations and network in your day-to-day work, as well as planning and conduct of regulatory interactions with health authorities. Regulatory Affairs is a truly multi-disciplinary with high professional standards and excellent opportunities for fast-paced professional development and career progression. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive change. With one of the highest organic growth rates within our industry Novo Nordisk is changing and growing rapidly. 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 50,000 employees to change the lives for the better for 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 Team Leader Morten Mikél McNair (+45 3077 7145). Deadline
6 August 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. We are hiring for multiple positions in Regulatory Affairs at the moment and therefore Managers from other departments might get access to your application. 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.
To succeed in this role you have:
At Novo Nordisk, your skills, dedication, and ambition help us change patient’s 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. About the department RA Device Combination Products is part of the RA CMC & Device Area in Novo Nordisk. In RA Device Combination Products, we are responsible for submission planning including applying intelligence and develop regulatory strategy for the device constituent of drug-device combination projects, to ensure minimum time to market and thus patients. This includes evaluating applicable guidelines, requirements and using external relations and network in your day-to-day work, as well as planning and conduct of regulatory interactions with health authorities. Regulatory Affairs is a truly multi-disciplinary with high professional standards and excellent opportunities for fast-paced professional development and career progression. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive change. With one of the highest organic growth rates within our industry Novo Nordisk is changing and growing rapidly. 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 50,000 employees to change the lives for the better for 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 Team Leader Morten Mikél McNair (+45 3077 7145). Deadline
6 August 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. We are hiring for multiple positions in Regulatory Affairs at the moment and therefore Managers from other departments might get access to your application. 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 7.7.2023, 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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