Regulatory Writer

Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger

Bagsværd

Do you want to have an impact on how we write regulatory submission documents for approval of new finished products? Do you thrive in an environment where you can ensure a smooth process and interaction with health authorities throughout a submission and Q&A process? Then apply now to one of our Regulatory Writer roles and join a team that will set the standards of regulatory submission documents for Novo Nordisk growing pipeline of new injectable drug products. The position We are now hiring several full-time writers at different levels of expertise (senior/professional), who will be strongly involved in defining the cross-department collaboration going forward. You can look forward to:
  • Defining and keeping the overview of the regulatory storyline.
  • Creating documentation for our portfolio to ensure that the required product's quality is fulfilled and thereby, securing patients’ safety.
  • Reviewing and implementing new documentation defining specifications, shelf-life stability studies, risk assessments, as well as regulatory submission documents to health authorities.
  • Using your regulatory expertise to provide feedback, secure answers to questions from various health authorities and keeping in touch with them.
  • Structuring and coordination of a complex documentation and submissions portfolio.
    • You will do this in cooperation with your colleagues across two departments in Injectable Finished Products (IFP) Manufacturing Development, in the development departments (CMC), QC, QA, production, and in regulatory affairs in Denmark and India. We offer an exciting and stimulating job that requires great energy, initiative, collaboration skills and flexibility. Qualifications Since we are looking for a couple of colleagues at different levels, we will be able to tailor the job to your level of experience. So we are looking both for you who have several years of experience and also for more junior candidates. Some of the qualifications we will be looking for are:
  • An academic degree in Science within Pharmacy, Chemistry, Engineering or a similar field.
  • Experience either from the pharmaceutical industry, the regulatory area or from the health authorities with either writing or reviewing regulatory documents.
  • Great communication skills in English, both spoken and written.
  • Excellent ability to plan and coordinate the writing work in line with an ambitious submission strategy.
  • You are fond of writing and good at creating an overview and prioritizing your tasks; even when deadline approaches.
    • As a person, you do well in busy environments, challenges do not scare you, and a quality mindset is at your core. Time management is well appreciated, as well as being an engaged team player. About the department In IFP Manufacturing Development we are responsible for the specifications of finished products and transfer of products from Chemistry, Manufacturing and Control (CMC) to our production facilities in Product Supply (PS) and the support of our aseptic productions. Further, we seek innovative solutions to and optimizations of all our processes and write the associated documents to authorities worldwide plus answering Q&A’s. The regulatory writers will have their base in two departments in IFP Manufacturing development – New Product Introduction, which is responsible for launch of all new drug products and Site Support and Improvement, which secure submissions of already marketed drug products. The regulatory writers will be allocated to a drug product and work across the two mentioned departments, so the role will to a high extent tie the two departments and in particular the regulatory thread throughout the submission. 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, Maria Berggård Silow at +45-34485056 or Associate Manager, Søren Alvarez Utoft, at +45-30759981. Deadline 10 April 2023. 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Bagsværd.

    Jobbet er oprettet på vores service den 20.3.2023, men kan have været deaktiveret og genaktiveret igen.

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

    Lignende jobs

    • Øvrige i København Ø

      Fri kontakt
      Senior Associates og Managere til Transaction Advisory Service i København. Vi mærker en stigende efterspørgsel efter rådgivning i forbindelse med køb og salg af virksomheder, herunder finansiel due diligence. Derfor søger vi Senior Associates og Managere til vores TAS team på Østerbro.
      • Øvrige
      • København Ø
      Få mere info

    • Øvrige i København

      Fri kontakt
      Ansøg senest: 30. april 2024 København On-site. Er du ambitiøs, målrettet og ikke bange for at rydde vanetænkning af bordet, så tror vi på, at du er vores nye Assisterende Restaurant Manager på Scandic Kødbyen.
      • Øvrige
      • København
      Få mere info

    • Øvrige i København K

      Fri kontakt
      Associate til IT Risk Assurance. Vi vækster i Grant Thorntons IT Risk Assurance & Advisory Services, og søger derfor en nyuddannet kollega. I afdelingen beskæftiger vi os med IT-revision, afgivelse af IT-erklæringer (ISAE 3402, ISAE 3000 mv.
      • Øvrige
      • København K
      Få mere info

    • Øvrige i København

      Fri kontakt
      Ansøg senest: 5. maj 2024 København On-site. Smiler du med øjnene, griber bolde fra alverdens retninger og elsker at hjælpe? Så tror vi på, at du er vores Bellboy på Scandic Spectrum. Vi ved, at du er skarp og handler hurtigt, når situationen kræver det.
      • Øvrige
      • København
      Få mere info

    Statistik over udbudte jobs som øvrige i Bagsværd

    Herunder ser du udviklingen i udbudte øvrige i Bagsværd over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal øvrige.

    Se flere statistikker her:
    Statistik over udbudte øvrige over tid

    Dato Alle jobs som øvrige
    29. april 2024 66
    28. april 2024 76
    27. april 2024 76
    26. april 2024 71
    25. april 2024 70
    24. april 2024 77
    23. april 2024 71
    22. april 2024 73
    21. april 2024 73
    20. april 2024 74
    19. april 2024 69
    18. april 2024 66
    17. april 2024 65
    16. april 2024 64
    15. april 2024 77
    14. april 2024 77
    13. april 2024 82
    12. april 2024 74
    11. april 2024 71
    10. april 2024 79
    9. april 2024 73
    8. april 2024 73
    7. april 2024 89
    6. april 2024 95
    5. april 2024 88
    4. april 2024 87
    3. april 2024 86
    2. april 2024 88
    1. april 2024 105
    31. marts 2024 110
    30. marts 2024 111
    Fold ud

    Populære søgninger

    Lignende søgeresultater

    Se alle populære søgninger