Expert in Regulatory Affairs - Primary Packaging

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Søborg

Novo Nordisk is on a tremendous growth journey, which leads to new and exciting challenges within primary packaging development. Do you want to develop your skills in primary packaging across emerging therapeutic area and innovative products serving millions of patients across the world? Then you could be our new Expert in regulatory matters related to primary packagingin the Regulatory Affairs (RA) Device department, which offers a multi-disciplinary environment with high standards and great career growth opportunities. 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. In connection hereto, we are looking for a Regulatory Affairs Expert in our area to drive the primary packaging submission activities. You will be working closely with colleagues across the organisation and leading key activities from early development through to clinical trials and up to marketing applications. Your responsibilities will include:
  • Driving the submission activities related to primary packaging in the cross-functional RA matrix teams and device development project teams
  • Ensuring alignment of planning and strategy across areas for primary packaging - 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
  • Actively representing Novo Nordisk both internally and externally, communicating within your area of expertise and impacting the regulatory landscape we operate in
  • Coaching and mentoring 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 shape 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 different 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 primary packaging materials
  • Knowledge of international legislation and standards, along with experience from the pharmaceutical industry
  • A previous track record of working with NDA and BLA submission, and/or MAA submission would be a strong advantage
  • Strong systematic mindset as you will be allocated to numerous projects
    • 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). 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 device constituent of drug-device combination projects and primary packaging, 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. 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 Team Leader, Morten Mikél McNair at +45 30777 145. Deadline
    16 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 3.11.2023, men kan have været deaktiveret og genaktiveret igen.

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    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Apoteker
    • Søborg
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