Regulatory Affairs Planning Partner

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Søborg

Are you motivated by ensuring effective planning of regulatory submissions worldwide? Do you thrive in an international environment, coordinating between different global stakeholders? And do you have a flair for working with data and business intelligence tools? You now have the great opportunity to join the Regulatory Affairs Planning and Processes team as a Regulatory Planning Partner in the Regulatory Affairs CMC and Device.
Apply now for a life-changing career! The position You will join a growing department and get your own individual area of responsibility, supporting part of the manufacturing portfolio. As a partner to affiliates, Regulatory Affairs (RA) areas, and Product Supply (PS), you will be responsible for the submission planning of global rollouts of life cycle management (LCM) variations, enabling the RA headquarter function to support affiliates with realistic, transparent plans.
The position requires analytical skills and the ability to create good, structured overviews of regulatory activities. We enable high-level reporting of detailed submission information and develop structured summaries for management and stakeholders around the organization. Focus is needed on following up and providing tactical plans with all affiliates across the world for LCM changes, submissions of a new manufacturing site, or an optimized process in manufacturing. Your main tasks will include:
  • Creating optimized plans with clear priorities to support the specific needs within your assigned organizational area of responsibility
  • Partnering with the Supply Chain area in PS, supporting both long- and short-term planning, entailing reliable plans for long-term utilization of the manufacturing network.
  • Developing structured overviews for submissions and approvals
  • Close collaboration with product-responsible leads and teams in RA Chemistry Manufacturing Control (CMC) and Device
  • Following up with regional offices and affiliates worldwide on submission plans
    • The RA Planning and Processes team is newly established, and you will also have the chance to shape how we work. You will be part of a transformational journey, actively participating in establishing new LCM processes and supporting IT solutions and tools for proactive submission planning. The job is based in Søborg, Denmark - however we embrace the hybrid workplace with a blend of on-site office-based work in Søborg, and home office in Denmark. Qualifications As a person, you need to be a dedicated team player, build good working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills. To be successful in this role, you need the following:
  • Master’s degree in Engineering, Pharmaceutical Sciences, Supply Chain Management, Business Administration, or another related field of study
  • Minimum 3 years of experience from a position in a regulatory affairs area in the pharmaceutical industry or responsibilities for, e.g., supply planning in an ever-changing environment
  • Project management track record
  • Hands-on experience navigating within an environment of tight timelines, high complexity, non-standard and diverse tasks, and a broad stakeholder landscape
  • An advanced level of written and spoken English is required
    • About the department Regulatory Affairs Planning and Processes is part of the Submission Excellence area in RA CMC & Device. RA CMC and Device is one of two headquarter-based regulatory functions with the responsibility to drive regulatory strategies for projects from the early phases to the LCM of marketed products worldwide. Submission Excellence is a relatively new area, consisting of four departments. We have the overall purpose of driving an ambitious LCM agenda to ensure flexibility in the supply network and to act as strategic partners for manufacturing and capacity expansion projects. We have a key role in setting the regulatory strategies, streamlining processes, and ensuring fast and efficient global rollout and approvals. RA Planning and Processes currently comprises six colleagues, with an expectation of further growth. The primary role is to manage the streamlined, well-governed planning of all regulatory submissions across the world. The main stakeholders are PS, Supply Chain, and regulatory functions in the global affiliates and headquarters, primarily within RA CMC & Device. The PS and Supply Chain areas are setting directions for how to best optimize and utilize 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 optimization. The profile of the colleagues in the team is very diverse, covering everything from regulatory experience to data and business analysts. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For more information, please contact Associate Director Julie Brinck Madsen at +45 3079 6372. Deadline 14 April 2023. Applications will be evaluated continuously when received, and candidates may be called for interviews before the deadline. 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. 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 26.3.2024, 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.
    • Apoteker
    • Søborg
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