Regulatory Writer

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Søborg

Do you wish to assist Novo Nordisk is ensuring a robust and stable supply of it’s products across the globe? You can do this by being a part of our regulatory writing team. The regulatory documents behind submissions of new products, transfers of current products and changes made to our existing products, are essential for our ability to produce our injectable finished products at our own production sites globally, as well as contract manufacturing organisations around the world. Apply now and join us! The position At Novo Nordisk, we are experiencing an unprecedented demand for our products, and we aim to support this bold supply challenge with effective and courageous efforts to provide speedy, accurate and concise regulatory documentation to facilitate rising up to this challenge. Supplementary to this, you will interact with internal stakeholders, affiliates and health authorities, when questions are received, as a result of a product submission. We respond, guided by the experience and knowledge of our process and product subject matter experts in our department. The job will consist of writing and reviewing reports and protocols, so an eye for detail is required. An ability to maintain structure and organisation, while managing several tasks across many stakeholders will be necessary to succeed. With so many stakeholders in our organisation, healthy collaborative skills are essential as well as the ability to work independently. Our team comprises of a group of process and product experts in formulation and filtration and regulatory writers who support and are guided by our process experts to keep up with the extensive workload of submission documentation. Expect great teamwork in order to achieve our team goals and in doing so, fulfil Novo Nordisk’s strategic goals for patient safety. Qualifications To succeed in this role, we expect you to have:
  • An academic degree in Life sciences or a similar field.
  • Experience from the pharmaceutical industry.
  • Great written and spoken English language skills.
  • Knowledge of drug product Manufacturing and experience with regulatory documentation is advantageous.
  • On a personal note you are meticulous, organized and have a structured and detail-oriented approach to everything you do. You take pride in delivering high quality documents and to do so you build and create a network to improve your knowledge and skills. You are curious and eager to ask the right questions as you know that learning fast can make a big difference. About the department Our team sits within the Site Support and Improvement department, within Manufacturing Development. Our purpose is to support the sites with our expertise knowledge for current manufacturing and ensure that future manufacturing is possible by supporting product launches and transfers. We are surrounded by Manufacturing development experts, who all also ensure that our products can get out to our patients as effectively as possible, in regard to compliance, requirements from authorities and improvement and innovative opportunities. We work cross the departments, as one Manufacturing Development organisation. 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 call Senior Manager Anneka Hastings at +4530798503 from August 11th. Deadline 20 August 2023. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible. 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 "Administrativ medarbejder", og befinder sig i kategorien "Kontor, handel og service".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 14.7.2023, 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.
    • Administrativ medarbejder
    • Søborg

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