(Senior) Regulatory Affairs Device Professional - Maternity Cover

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Exciting Career Opportunity in Regulatory Affairs Combination Products! 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 (RA) Device Professional for combination product development in the RA Device department. Apply now for this exciting job opportunity! The position
[xxxxx] 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. You will be working closely with colleagues across the organisation, and you will be involved in key activities from early development through to clinical trials and up to Notified Body submission and/or marketing applications. Your responsibilities will include:
  • Support RA strategy and drive submission planning for the device constituent parts of Combination products, incl. Notified Body Opinions, Clinical trials, Marketing Authorisation Applications and Meeting packages for Health Authorities
  • Represent RA Device in the cross-functional RA matrix teams and device development project team
  • Ensure alignment of planning and strategy across areas - your contribution 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 [xxxxx] both internally and externally, communicating within your area of expertise and impacting the regulatory landscape in which we operate in
    • 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 or an equivalent in Science, Engineering, Pharmacy, or related field of study
  • Relevant work experience in a global role within e.g. combination products and/or medical devices
  • Familiarity with global regulations and device standards (e.g., ISO11608) in addition to pharmaceutical industry experience Fluency in written and spoken English
    • On a personal note, this role requires outstanding communication abilities and a proactive, solution-oriented mindset. Planning and coordination skills to handle complex tasks are also essential attributes. You exhibit a strong sense of self-motivation and 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. In RA Device, 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 [xxxxx]
    At [xxxxx], 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 Laetitia Hourman at [xxxxx] or Bilal Ghazal at [xxxxx] Deadline
    22 October 2024. 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 [xxxxx] 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 14.10.2024, men kan have været deaktiveret og genaktiveret igen.

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    • Apoteker
    • Søborg
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