Principal Regulatory Specialist

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Søborg

Are you able to take the lead and drive regulatory strategies for high impact projects? Would you like to work together with experts across multiple functions in a global environment? Then join Global Regulatory Affairs (RA) team at Novo Nordisk and be part of an engaging environment where dedicated individuals work to gain approval for the company's innovative medicines worldwide. This position offers a great opportunity to be part of a late phase drug development project approaching marketing authorisation applications on a global scale . Apply now! The position As a Principal Regulatory Specialist, you are expected to demonstrate strong leadership by setting the regulatory strategic direction in development projects and in highly scientific settings. Join a project focused on rare diseases that is currently in the late stages of development and is about to undergo an exciting phase of global regulatory submissions. Your key responsibilities include:
  • Oversee regulatory strategy and provide creative regulatory expertise and tactics, with a particular emphasis on later stages of development stages
  • Demonstrate regulatory science knowledge, including a deep understanding of regulatory processes and global development project activities
  • Plan and drive all regulatory activities and deliverables according to agreed timelines and quality
  • Manage specific deliverables such as regulatory marketing authorization submissions and approvals globally
  • Drive and coordinate preparation of meeting packages to Health Authorities, conducting Health Authority interactions, and for submission and approval of clinical trial applications
    • You will work as an integrated part of global cross-functional project-teams with stakeholders ranging from research to development, market access, commercial and to our Novo Nordisk affiliates worldwide. You will report to the Associate Director of RA Haemoglobinophaties and Early Development and take active part in department-related activities, including improvement projects across RA. Qualifications To succeed in this role, you need the following:
  • Master’s degree within life sciences with minimum of 8 years of relevant experience and/ or a relevant PhD with minimum of 5 years of relevant working experience
  • Solid experience in preparing and delivering global regulatory strategies, including employment of expedited and accelerated pathways across the major regulatory agencies globally and handling of regulatory documentation for pharmaceutical development (quality, non-clinical and clinical)
  • Pharmaceutical industry knowledge and experience in interacting directly with regulatory authorities on an international scale
  • Strong negotiation skills and a sound business understanding
  • Fluent written and spoken English
    • As an individual, it is essential to be able to think creatively, come up with unconventional solutions, and deal with ambiguity and complexity. The job requires that you are well organized, work structured and have solid problem-solving capabilities. You should also be able to maintain a positive attitude even when under pressure. You are an excellent communicator who can cooperate and influence at any organizational level. About the department In RA Haemoglobinopathies and Early Development, we contribute to the development of treatments within Rare Blood Disorders with a pipeline including a variety of different modalities and technologies. Our team consists of 7 dedicated and highly engaged employees with diverse background and experience. We are responsible for developing, implementing, and executing global regulatory strategies and operational activities in alignment with the development plan. Our focus is on data, digital health, devices, and diagnostics to bring innovative solutions to patients worldwide. We drive label development, health authority interactions and regulatory submissions, hereunder initial marketing authorisation applications, pediatric plans, and clinical trial applications as well as lifecycle management activities in close collaboration with our affiliates and global stakeholders. 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 Marie Aavang Geist at +45 3448 0290. Deadline 18 April 2023. Relevant candidates will be invited for interview also before deadline. You do not need to attach a cover letter to your application – just include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV. This makes for a better and less biased process. 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.


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    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 20.3.2023, 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.
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    • Søborg
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