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RegSmart Life Science AB was founded in 2019 with the vision of creating a company based on solid regulatory experience and broad scientific knowledge. The common denominator for RegSmart employees is a comprehensive and in-depth knowledge of strategic regulatory issues covering pharmaceuticals and medical device.

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Join the
RegSmart team

 

Senior regulatory specialist

We do nothing regular within regulatory!

Have you worked with regulatory management in the licensing of medicinal products? At RegSmart you will use your expertise as a consultant, to guide and support companies through complex regulatory challenges and operations.

As a senior consultant you will support clients with both strategy and hands-on work. You will manage multiple projects, sometimes in a leading role, working closely with experienced colleagues while enjoying a high degree of independence.

The role includes:

  • Provide advice on licensing strategies
  • Lead regulatory projects pre- and post-authorisation
  • Execute regulatory submissions and coordinate regulatory procedures 
  • eCTD compilations and publishing

Depending on your expertise and client needs, you may:

  • Prepare or review regulatory documentation
  • Support clients in their communication with CMOs 
  • Pharmacovigilance 

This is a permanent full-time role based in our Uppsala office (or a hybrid solution).

Qualifications

  • Degree in pharmacy or similar
  • Background from pharma industry, regulatory authority or consultancy
  • Solid experience in regulatory management and operations for medicinal products 
  • Excellent English and Swedish skills, spoken and written

About RegSmart

We combine regulatory expertise with commercial understanding and scientific experience. After all, it is all about managing risks and expectations. Making sure that your time and money is spent in the best way. Spearheading your work to the next phase. Always with eyes both on the bigger picture and the details. Because both are essential for the end result.

Application and contact

Please contact Maria Santesson for more information. Interviews will be held on an ongoing basis. 

Last application date: 15 February

Work with us

Center for Translational Research Sweden

RegSmart is part of the group Center for Translational Research Sweden (CTR). Other companies in the same group are CTC Clinical Trial Consultants ABLablytica Life ScienceToxicology Knowledge Team SwedenRegfileMetaSafe and QAlliance.

Meet our team

The team