Senior Operating Model Lead - Regulatory Affairs CMC & Device

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Søborg

Do you want to be part of shaping Regulatory Affairs (RA) CMC (Chemistry, Manufacturing, and Controls) & Device future operating model and global footprint? Would you like to work across functions with broad exposure to stakeholders? Are you an experienced leader, with a proven track record of driving change initiatives and improvement projects? If so, then become a part of Novo Nordisk - a global pharmaceutical leader dedicated to improving the lives of millions. Apply today and join us for a life-changing career! The Position As the Senior Operating Model Lead in Regulatory Affairs for CMC & Device, your responsibilities will include facilitating direction setting, ensuring a coordinated approach, and driving change within the evolving operating model and expanding footprint of RA CMC & Device. Your tasks will include:
  • Preparing and executing projects and change initiatives of high complexity in close collaboration with leaders and employees, including analysis, planning, managing risks, communication, implementation.
  • Building a shared understanding of the current state across the area, which can serve as a basis for outlining and facilitating decision making towards a common strategy.
  • Directing communication towards RA CMC & Device leaders and cross-functional stakeholders, ensuring strategic alignment and buy-in.
  • Acting as a trusted sparring partner to RA CMC & Device leaders and collaborate with key stakeholders both within Development, Product Supply and across the value chain in Novo Nordisk.
    • Qualifications To succeed in this role, you need to have a Master’s degree in a relevant field, coupled with 8-10 years of relevant work experience, preferably from the pharmaceutical industry. In addition to the above, you should also demonstrate:
  • Extensive project management expertise with a strong track record of driving cross-functional projects as well as change management initiatives including e.g., analysis, planning, communication, implementation.
  • Significant leadership experience with a track record of developing, leading and influencing teams, ways of working, behaviours.
  • Experience with collaboration across departments and organisational levels including interacting with senior leadership.
  • Strong analytical skills, strategic mindset and effectively managing multiple competing priorities.
  • Understanding of Regulatory Affairs and/or interfacing functions in the pharmaceutical industry is an advantage, but not a requirement.
    • Our company operates in an international environment, and we expect excellent written and verbal communication skills in English from all candidates applying for this role. On a personal level, you are expected to work and thrive in a complex, dynamic environment. You need to be passionate about what you do and take pride in delivering high quality results. Finally, you should have a positive, “can-do” attitude with personal drive, results driven and enjoy being a part of high-performing team focused on cross-organizational collaboration. About The Department RA CMC & Device is accountable for all regulatory activities related to CMC and Medical Devices for both development projects and marketed products. We are a global function of more than 200 colleagues located primarily in Søborg, Denmark and Bangalore, India, as well as colleagues in US, UK and France. The area has grown significantly in recent years with plans for continued growth. RA CMC & Device has an increasingly important function in Novo Nordisk due to the corporate ambition of bringing new products and innovation progressively faster to market by shortening development timelines and optimise and expand production capacities. The function is represented across the value chain in governance and project teams and act as important business partners by soliciting tough decisions based on regulatory requirements, business needs and patient safety. Our ambition to be the best in the world at doing this! Working at Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our careers is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 50,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Morten Flyvholm (+45 34486695), Vice President of RA CMC Emerging Technologies. Deadline
    20 November 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. 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 "Apoteker", og befinder sig i kategorien "Sundhed og forskning".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 7.11.2023, men kan have været deaktiveret og genaktiveret igen.

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    • Apoteker
    • Søborg
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