Senior Regulatory Expert

2 days ago


Copenhagen, Copenhagen, Denmark Macure Pharma Full time

We are looking for a Senior Regulatory Expert to join our team at Macure Pharma. As a key member of our Regulatory Affairs department, you will be responsible for implementing and optimizing our new Submission Publishing Tool. Your expertise in eCTD publishing and regulatory submission workflows will be instrumental in shaping our digital regulatory processes.

Responsibilities:
  • Playing a lead role in the implementation of our new Publishing Tool, leveraging your knowledge of EDMS systems and workflow optimization techniques.
  • Compiling and formatting regulatory submissions in eCTD format, ensuring accuracy and compliance.
  • Developing and maintaining SOPs to ensure regulatory compliance and operational excellence.
  • Streamlining workflows and driving efficiency within Regulatory Affairs, identifying opportunities for process improvements.
  • Supporting submission processes for National, MRP, and DCP procedures, as well as regulatory lifecycle management and interactions with CMOs and health authorities.

This is an exciting opportunity to work in a dynamic environment and contribute to the growth and success of Macure Pharma.



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