Regulatory Affairs Expert
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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 our new Regulatory Affairs Expert in the Regulatory Affairs (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 Expert in our area, you will be working closely with colleagues across the organisation and leading key activities from early development through to clinical trials and up to Notified Body submission and subsequent marketing applications. Your main responsibilities will include:
• Represent RA Device in the cross-functional RA matrix teams and device development project teams, ensuring alignment of planning and strategy across areas.
• Determine the regulatory device strategy.
• Establish and maintain dialogue with authorities and support the projects as well as the affiliates.
• Establish a global network and enhance your knowledge by participating in innovative drug-device combination product projects involving highly skilled people – all experts within their field.
• Work in a fast-paced environment with tight deadlines and deal with the challenging reality of international communication across time zones, cultures, and circumstances. Furthermore, it is anticipated that you will play an active role in representing Novo Nordisk both internally and externally, communicating within your area of expertise and impacting the regulatory landscape in which we operate in. Most importantly, you will have the possibility to influence your role according to your interests and specialization. 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
You will be a great asset to our team because you have:
• A MSc degree in Science, Engineering, Pharmacy, or other relevant education and professional proficiency in English.
• Proven track record and extensive knowledge of working with regulations of combination products and/or medical devices.
• Knowledge of international legislation and standards.
• Experience from the pharmaceutical industry as well as demonstrating excellent planning and coordination skills to handle complex tasks for yourself and others (an advantage)
• Coaching or mentoring background to lead junior colleagues in the team, while displaying an inclusive mindset and respect of diversities and cultures. As a person, you are self-driven, have a strategic mind-set and can make the right regulatory decisions – and thus drive the regulatory agenda. With a proactive and innovative approach, you can 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, as well as communicating with scientific insight with the health authorities. 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 Product 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 department 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. 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, stiving 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 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 Josephine Sparlund at +45 3077 5214. Deadline
11 June 2023 Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. #LI-AMS1 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.
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 Expert in our area, you will be working closely with colleagues across the organisation and leading key activities from early development through to clinical trials and up to Notified Body submission and subsequent marketing applications. Your main responsibilities will include:
• Represent RA Device in the cross-functional RA matrix teams and device development project teams, ensuring alignment of planning and strategy across areas.
• Determine the regulatory device strategy.
• Establish and maintain dialogue with authorities and support the projects as well as the affiliates.
• Establish a global network and enhance your knowledge by participating in innovative drug-device combination product projects involving highly skilled people – all experts within their field.
• Work in a fast-paced environment with tight deadlines and deal with the challenging reality of international communication across time zones, cultures, and circumstances. Furthermore, it is anticipated that you will play an active role in representing Novo Nordisk both internally and externally, communicating within your area of expertise and impacting the regulatory landscape in which we operate in. Most importantly, you will have the possibility to influence your role according to your interests and specialization. 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
You will be a great asset to our team because you have:
• A MSc degree in Science, Engineering, Pharmacy, or other relevant education and professional proficiency in English.
• Proven track record and extensive knowledge of working with regulations of combination products and/or medical devices.
• Knowledge of international legislation and standards.
• Experience from the pharmaceutical industry as well as demonstrating excellent planning and coordination skills to handle complex tasks for yourself and others (an advantage)
• Coaching or mentoring background to lead junior colleagues in the team, while displaying an inclusive mindset and respect of diversities and cultures. As a person, you are self-driven, have a strategic mind-set and can make the right regulatory decisions – and thus drive the regulatory agenda. With a proactive and innovative approach, you can 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, as well as communicating with scientific insight with the health authorities. 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 Product 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 department 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. 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, stiving 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 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 Josephine Sparlund at +45 3077 5214. Deadline
11 June 2023 Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. #LI-AMS1 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 19.5.2023, 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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