Expert within Regulatory Affairs Combination Products
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Søborg
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 expert within Regulatory Affairs (RA) for combination product development in the RA Device department. Apply now for this exciting job opportunity! The position Novo Nordisk is evolving its portfolio in medical device and drug-device combination product development across an exciting array of innovative products, including biopharmaceuticals and new delivery systems. As an 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/or marketing applications. Your responsibilities will include: Represent RA Device in the cross-functional RA matrix teams and device development project teams Ensure alignment of planning and strategy across areas - your regulatory expertise is needed to determine the regulatory strategy, establish, and maintain dialogue with authorities and support the projects as well as the affiliates 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 Coach/mentor more junior colleagues in the team, while role modelling an inclusive mindset and respect of diversities and culture You will get a unique opportunity to establish a global network and to enhance your knowledge by participating in innovative medical device and drug-device combination product projects involving highly skilled people – all experts within their field. 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 An ideal candidate is expected to have: Master’s degree in Science, Engineering, Pharmacy, or other relevant education Proven and substantial work experience in a global role involving the regulations of combination products and/or medical devices Knowledge of international legislation and standards, along with experience from the pharmaceutical industry A previous track record of working with CE marking, NBOp, 510K, CB30, NDA and BLA submission, and/or MAA submission would be a strong plus Fluency in written and spoken English On a personal note, this role requires outstanding communication abilities and a proactive, solution-oriented mindset. Proficiency in providing guidance and mentorship to colleagues and excellent planning and coordination skills to handle complex tasks are also essential attributes. It is important that you exhibit a strong sense of self-motivation and consistently demonstrate the ability to make informed regulatory decisions, thereby advancing our regulatory initiatives. With a proactive and innovative approach, you can bring valuable input and set the strategic direction for the project(s). Furthermore, you should be able to communicate complex regulatory topics to a diverse range of stakeholders, spanning from Research & Development to production and marketing, and effectively engaging with health authorities through scientifically informed discourse. About the department RA Device is part of the RA CMC & Device Area in Novo Nordisk. We are responsible for submission planning including applying intelligence and develop regulatory strategy for the medical device and 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 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 Josephine Sparlund at +45 30775214 or Morten Mikél McNair at +45 30777145. Deadline 26 November 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We conduct a thorough manual review of each CV, with a particular focus on the tasks you were engaged in during your tenure at various workplaces. Therefore, please ensure that you provide comprehensive and detailed information. This will enable us to gain a clearer understanding of your roles and responsibilities. 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 "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 6.10.2023, 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.
- Apoteker
- Søborg
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