Regulatory Integration Lead

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Søborg

Do you want to be a part of shaping how we in Regulatory Affairs work with data integrations/migrations in the exciting context of mergers & acquisitions? If you are ready to take on the challenge, we encourage you to apply for this exciting position as Regulatory Integration Lead. The position As Regulatory Integration Lead, you will drive activities that enable us to manage regulatory activities across a dynamic product portfolio, with a primary focus on securing a smooth and effective integration of core documents into our digital regulatory management platform Vault RIM in connection with acquisitions. Your main responsibilities include:
  • Collaborating with cross-functional product teams to develop and implement integration plans, ensuring alignment with business objectives and timelines.
  • Leading the migration of regulatory documents into Vault RIM in connection with acquisitions, ensuring a smooth transition and compliance with regulatory requirements.
  • Monitoring and reporting on the progress of integration activities, identifying and mitigating risks as necessary.
  • Provide guidance and support to project teams, ensuring adherence to regulatory standards and best practices.
  • Establish a standard integration process and drive adoption by product teams and document owners.
  • Leveraging digital solutions and AI to secure process scalability, robustness, and compliance.
  • Qualifications The ideal candidate has:
  • A M.Sc. in a relevant field, such as science, pharmacy, or equivalent.
  • Minimum 3 years of experience in the pharmaceutical industry, preferably within Regulatory Affairs.
  • Experience working with Vault RIM or other regulatory IT platforms is required.
  • Experience working with process design/improvements and project management is an advantage.
  • High proficiency in English
  • As a person, you are curious to learn, well organised, and a proactive problem solver. You enjoy working in a diverse team and being part of a global project-centric organisation and you are a strong collaborator. You thrive in a dynamic environment and have a can-do attitude as well as a healthy sense of humor. Working with matrix teams, you focus on jointly moving projects, work independently, and bring an innovative mindset seeking novel solutions to the challenges we face. About the department You will have the unique opportunity to be part of a strategically crucial business transformation across multiple processes and geographies and take active part in shaping the way Regulatory Affairs will work in the future. You will join the RA Submission Systems department that plays a key role to support and enable this transformation. Global Regulatory Affairs is an exciting area involved across the full value chain. We are responsible for global regulatory strategies to obtain and maintain regulatory licenses for current and future products, responsive to the worldwide business needs of Novo Nordisk. You will work in a fast-paced environment where it is important to be able to manage deadlines in a complex context of international communication across time zones, cultures, and circumstances. The atmosphere in the team is informal and good humor is always welcome. 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. Contact For further information please contact Sascha Mette Honig +4530751266. Deadline 5 June 2024. 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. 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 11.4.2024, 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.
    • Apoteker
    • Søborg

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