Regulatory Lead to pioneer development project 1 views



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Job Description:

Overall responsible for regulatory strategies and deliverables via external partner

Your overall objective is to bring a new product to the market by 2025. You and the development team will focus on developing new products based on existing APIs in collaboration with external partners that you will help to identify, select and manage. As Regulatory Lead you will be responsible for regulatory strategies and deliverables via the external partner. As such, good vendor management will be critical for your success. Your primary tasks will be to:

  • Contribute to identify and select external development partners
  • Develop regulatory strategies – in close dialogue with external partner(s)
  • Ensure on-going progress according to plans – vendor management
  • Ensure high quality and solid documentation – vendor management
  • Deliver stage gate reports and related project communication
  • Contribute to development of project business plans and recommendations

As part of a small team you will work at all levels from high-level strategy to hands-on operational tasks. Ideally, you will be based at our HQ in Ballerup, Greater Copenhagen but if you are our perfect match, we are open for a dialogue regarding alternative solutions.

10+ years’ of international RA experience

We are looking for a pioneer that thrives on breaking new land. If that person is you, you are generally very curious and you have the courage to enter unknown paths and the ability to find the most feasible regulatory pathway. Additionally, you can see opportunities and possible solutions when facing tough challenges, and you have the persistency to keep on going. Your professional skillset comprises:

  • A natural science degree
  • 10+ years’ experience from working with RA across several functions
  • Experience from working with regulatory authorities in international markets
  • A proven track record of applications without dependency on approvals in the EU, the US, Canada and Australia
  • A good understanding of drug development and LCM
  • Project management experience

More Information

  • Country DK - Denmark
  • Job Location Ballerup
  • Minimum Qualification Bachelor's
  • Job Category Other
  • Job Shift Day Shift
  • Gender Requirement Male
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  • Industry Recruitment / Employment Firms
  • Company Address Pakistan
  • No of Employees 1 - 50
  • Operating Since 01/10/2018