Global Regulatory Lead, Early Development Projects

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

Søborg

Are you able to take the lead and drive regulatory strategies for high impact projects, and would you like to work together with experts across multiple functions in a global environment? Then come and join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s medicines to bring innovative treatment to patients across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. Apply now! The position We are looking for a Global Regulatory Lead for early development NASH ( Non-alcoholic steatohepatitis ) projects. It is a strategic position and requires leadership skills, scientific and regulatory background, and drug development proficiency. You will work as an integrated part of global cross-functional project teams with stakeholders from research, development, market access, commercial and our Novo Nordisk affiliates worldwide. You will report to the Senior Director of RA NASH and take active part in department related activities, including improvement projects across RA. Although we prefer that you work from our office in Søborg, Denmark, there is a possibility to work remotely with the right candidate. Your tasks will be to:
  • Be accountable for the regulatory strategy and provide innovative regulatory expertise and tactics throughout the research and development stages and to proactively connect with the entire value chain.
  • Demonstrate subject matter expertise within regulatory science including but not limited to profound knowledge about regulatory processes and activities related to a global development project.
  • Be responsible for planning and driving all regulatory activities and deliverables according to agreed timelines and quality.
  • You will be the overall accountable for specific deliverables such as submission and approval of clinical trial applications, driving and coordinating preparation of meeting packages to Health Authorities, conducting Health Authority interactions, and regulatory marketing authorization submissions and approvals globally.
    • With regulatory leadership you will have a large responsibility, and you will have a major influence and impact on our project development and roll out globally. You will assume the role as challenger who makes an impact, seeks solutions, and drives innovations. By incorporating clinical diagnostics and device aspects into our product lifecycle, we are not only pursuing drug but also product development. Qualifications You have an academic degree such as master’s degree or a Ph.D. combined with several years of regulatory experience in the pharmaceutical industry with a thorough understanding of the R&D (Research & Development) value chain. We expect you to:
  • Have solid experience in preparing and delivering on global regulatory strategies, including employment of expedited and accelerated pathways across the major regulatory agencies globally and handling regulatory documentation for pharmaceutical development (quality, non-clinical and clinical).
  • Have a strong pharmaceutical industry knowledge and experience in interacting directly with regulatory authorities on an international scale.
  • Demonstrate proactive and strong leadership and know how to set direction, lead, and motivate a team to work for joint objectives.
  • Be a team player who assist your colleagues, and you must have an inclusive mindset and respect the diversity in others.
  • Have strong negotiation skills and a sound business understanding.
  • Be comfortable using your fluent written and spoken English daily.
    • On a personal level, you need to think out of the box, suggest unconventional solutions, work with ambiguity and complexity. You are well organized and have solid problem-solving capabilities. Excellent communication and stakeholder management skills are necessary to cooperate and influence with others at an organization level. Finally, it is an advantage if you have a good sense of humor, and you can keep your spirits high even when under pressure. About the department You will join the expanding department of RA NASH situated in Søborg, Denmark. We work on development projects ranging from early research entailing candidate selection through to late-stage development and filing of Marketing Authorization applications globally. We have a broad and expanding portfolio within the serious chronic liver disease NASH; an indication that severely affects millions of people globally and with no current treatment options. We are currently 11 dedicated and highly engaged employees in the department with diverse background and experience. We work in a flexible set-up where trust and openness, sparring, challenge, and knowledge sharing foster an inclusive and innovative culture we all enjoy being part of. The atmosphere is informal and good humour is always welcome. 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Tara Elvang at +45 3075 2456. Deadline We will conduct interview on an ongoing basis, so please send your application as soon as possible, but no later than 26 February 2023. To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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 Søborg.

    Jobbet er oprettet på vores service den 10.2.2023, 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
    • Søborg
    Rapportér

    Lignende jobs

    • Senior Associates og Managers til Transaction Advi...

      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 Frederiksberg C

      Fri kontakt
      Se https://www.digitaldisruptionmedia.com/jobs/piccolinepiccolo-sges-snarest
      • Øvrige
      • Frederiksberg C
      Få mere info

    • Breakfast Manager, fuldtid, Scandic Webers

      Fri kontakt
      Er du ambitiøs, målrettet og ikke bange for at rydde vanetænkning af bordet, så tror vi på, at du er vores nye Breakfast Manager på Scandic Webers. Vi ved, at du ta’r ansvar og har ro i maven med det fulde overblik. Du er god til at organisere, købe ind, lede og dele din viden.
      • Øvrige
      • København
      Få mere info

    • Revenue Manager, Scandic Hotel A/S - Support Offic...

      Fri kontakt
      Brænder du for tal, strategi og optimering og har du lyst til at være en del af det danske Revenue Management Team hos Nordens førende hotelkæde? Så tror vi på, at du er vores nye Revenue Manager med interesse for analyse og tal på Scandic Support Office i København.
      • Øvrige
      • København
      Få mere info

    Statistik over udbudte jobs som øvrige i Søborg

    Herunder ser du udviklingen i udbudte øvrige i Søborg 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 i Søborg over tid

    Dato Alle jobs som øvrige
    26. november 2024 59
    25. november 2024 58
    24. november 2024 63
    23. november 2024 61
    22. november 2024 61
    21. november 2024 63
    20. november 2024 64
    19. november 2024 60
    18. november 2024 62
    17. november 2024 63
    16. november 2024 65
    15. november 2024 63
    14. november 2024 63
    13. november 2024 65
    12. november 2024 61
    11. november 2024 58
    10. november 2024 60
    9. november 2024 60
    8. november 2024 59
    7. november 2024 60
    6. november 2024 58
    5. november 2024 56
    4. november 2024 55
    3. november 2024 57
    2. november 2024 57
    1. november 2024 57
    31. oktober 2024 55
    30. oktober 2024 56
    29. oktober 2024 56
    28. oktober 2024 56
    27. oktober 2024 56
    Fold ud

    Populære søgninger

    Lignende søgeresultater

    Se alle populære søgninger