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Regulatory Operations Expert

Who are we?

BASE life science is a business and technology consulting company founded in 2007. Working exclusively within the life science industry, BASE is specialised in working on the customer side of IT projects and systems.

From our offices in Denmark and Switzerland, we serve customers across Europe. Over the last three years, we have experienced substantial growth. We believe that the combination of a problem-solving mindset and a tailored approach to each client will deliver significant value and lasting impact.

BASE life science is looking for Senior Regulatory Operations Experts to be based in Denmark or Switzerland

We are currently expanding our Clinical practice with a handful of dedicated and passionate masterminds, who will become an essential part of growing our offering within digital transformation of clinical operations. The practice collaborates with other practices within BASE life science including Analytics/AI, Data engineering, and operations services, to deliver a set of complete solutions for customers.

As a Senior Regulatory Affairs Expert, your main task will be to understand, challenge, and formulate customer requirements. In collaboration with the analytics and operations practices, you will help define and implement optimised regulatory processes and data transformations, enabling further digitalisation of our customers’ regulatory processes.

Required skills and experience:

  • 5+ years’ relevant experience
  • High level of drive with an independent approach and high genuine affinity with problem solving
  • Ability to structure tasks and know-how to process details in an efficient manner
  • In-depth understanding of clinical operations and trial management processes
  • Strong network of industry peers, players, and experts
  • Working experience using and/or implementing IT applications supporting clinical processes like Submissions and RIM
  • Operational experience in applying and following regulatory quality requirements and processes (GCP certification is expected)
  • Experience working with regulatory documents and data sets, including data modelling, data management, data quality, data integration, and data cleansing
  • Experience in conducting knowledge and innovation workshops with focus on optimisations and adoption of new technology, unlocking the value of regulatory content

Lastly, we expect you to be up to date on the latest trends within digital transformation of regulatory guidelines, as we desire likeminded people, who are curious and constantly seek new knowledge.

What do we offer?

In short, we offer you an entrepreneurial work environment, where you will be able to quickly make an impact for our customers and for the development of our clinical practice. We also offer:

  • A steady growing workplace with flexible working hours
  • Ongoing learning and development opportunities
  • Informal style of management and communication with direct access to top management
  • An inspiring work environment with many social events
  • Friday breakfast meetings to catch up with colleagues

Are you intrigued?

If you would like to hear more, please reach out to:

Partner Martin Woergaard at mwoe@baselifescience.com (+45 53690034)

Partner Jacob Winkler at jwin@baselifescience.com (+45 53737034)

Please send your CV and cover letter to application@baselifescience.com. We will continuously evaluate incoming applications.

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