Associate Director, RA Planning and Processes

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Søborg

Do you have the skills and expertise to streamline processes and improve business performance? Are you equipped with strong analytical abilities and effective planning strategies? Would you like to apply your knowledge to contribute to the innovation and excellence of Novo Nordisk - a global industry leader? Then you may want to consider this exciting opportunity for the role of Associate Director in Regulatory Affairs (RA) Planning and Processes. Apply now! The position As an Associate Director, you will have the daily leadership responsibilities for the people in your team and set direction to ensure that we as a team provide best in class regulatory strategies to the projects we support, thereby ensuring fast submissions and approvals globally. Key responsibilities include:
  • Oversee the development, optimisation, and execution of regulatory processes and planning strategies
  • Identify opportunities for process improvements and implement new methodologies to enhance the efficiency and effectiveness of planning and processes
  • Act as a strategic partner by aligning regulatory requirements with the optimisation plans
  • Collaborate closely with various stakeholders at all organisational levels
  • Provide leadership and guidance to a team of colleagues, ensuring effective management of day-to-day planning activities
  • Our philosophy is clear: When you thrive and are appropriately challenged in your job, you are the best version of yourself and the most valuable colleague. Being part of an organisation that works as a strategic business partner across various parts of a product’s life cycle, you have exciting opportunities in both the department and across the company and you are expected to carry on this mindset when developing yourself as well as your team. Our organisation operates worldwide, and the role is in Søborg, Denmark. Qualifications An ideal candidate is expected to have:
  • A cademic degree, ideally a Master's, coupled with relevant work experience – not strictly limited to pharmaceutical or regulatory affairs
  • +5 years of leadership experience marked by a proven track record of achieving impactful and successful outcomes
  • Significant understanding of process setup and data management concepts
  • Proficiency in business acumen
  • Ability to work effectively in a corporate environment with diverse stakeholders
  • Fluency in English, both written and verbal
  • As a person, you are an ambitious individual with a proactive mindset, taking the lead in overcoming challenges and guiding your team forward. Your strong business acumen empowers those around you through constructive feedback and guidance. You need to have excellent communication skills and ability to effectively collaborate within a corporate environment involving multiple stakeholders. About the department RA CMC & Device is one of two head quarter based regulatory functions, with the responsibility to drive regulatory strategies for projects from early phases to life cycle management (LCM) of marketed products worldwide. Submission Excellence is a relatively new area, consisting of 4 departments. We have the overall purpose of driving a continuously ambitious LCM agenda to ensure flexibility in the supply network and to act as strategic partner to manufacturing and capacity expansion projects. We have a key role in setting the regulatory strategies for expansion projects, streamlining processes, and ensuring fast and efficient global roll out and approvals. “RA Planning & Processes” currently comprise of 5 colleagues, with an expectation of further growth. The primary role is to manage streamlined, well governed planning of all regulatory submissions across the world. The main stakeholders are Product Supply, Supply Chain, Regulatory functions in the global affiliates and headquarter, here primarily within RA CMC & Device. Product Supply, Supply Chain is setting direction for how to best optimise and utilise our global manufacturing network and our role is to be a strategic partner balancing regulatory requirements into an optimal plan for executing on approvals of manufacturing site additions and optimisations. The profile of the colleagues in the team is very diverse, covering everything from regulatory experienced to data and business analysts. As this department and the area in general is newly established, a big part of the role as Associate Director will be to join this journey, establishing new ways of working, while in the meantime managing the day-to-day planning and tasks. 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 Director Malene Østergaard Jørgensen, +45 30795844. Deadline 8 October 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 26.9.2023, men kan have været deaktiveret og genaktiveret igen.

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

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