Global Regulatory Lead, Rare Diseases

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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 lead the regulatory strategy for an asset in Phase 2 approaching Phase 3 . Apply now! The position As a Global Regulatory Lead in Rare Diseases , you are expected to demonstrate strong leadership by setting the regulatory strategic direction in development projects and in highly scientific settings. 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. In this role, you will:
  • Be accountable for the regulatory strategy

  • Provide innovative regulatory expertise and tactics with special focus on the later development stages

  • 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 overall responsible 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

    • You will have the chance to join a project in its advanced development stage, focusing on a rare disease. The project is poised to enter an exciting phase of engaging with regulatory authorities and strategizing for phase 3. The job offers ample opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines. Your collaborative skills will be trained well and further developed, and you can expect to build an extensive internal network – just like we expect you to maintain your external networks to benchmark and bring up discussions with peers. 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 Rare Blood Disorders, we contribute to the development of treatments within rare diseases like Sickle Cell Disease and Thalassemia where there is a high unmet need for treatment on a global scale. The pipeline includes a variety of different modalities and technologies. We are a team of 10 dedicated and highly engaged employees with diverse backgrounds and experiences. We value trust and openness and work in an environment where sharing of knowledge, new ideas, and innovative approaches to regulatory strategy and tactics are highly appreciated. We are an integrated part of the global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and tactics and provide regulatory expertise to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications. We have a strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams with colleagues from RA CMC, RA device, US etc., and together form a team with the capacity to execute ambitions plans. 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 10 September 2023. Relevant candidates will be invited for interview also before deadline. Should you wish to learn more about Regulatory Affairs careers, here may be a good place for you to begin: https://www.novonordisk.com/careers/career-areas/research-and-development/regulatory-affairs-careers.html 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.


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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 24.8.2023, men kan have været deaktiveret og genaktiveret igen.

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