Regulatory Publishing Specialist

6 days ago


Copenhagen, Copenhagen, Denmark Macure Pharma Full time

As a Senior Regulatory Publisher & Submission Manager at Macure Pharma, you will play a key role in shaping regulatory processes and implementing our new Submission Publishing Tool.

Your responsibilities will include:

  • Compiling, formatting, and validating regulatory submissions in eCTD.
  • Implementing and optimizing our digital document management system to streamline workflows and ensure operational excellence.
  • Developing and maintaining Standard Operating Procedures (SOPs) to ensure regulatory compliance and process efficiency.
  • Supporting submission processes for National, MRP, and DCP procedures, as well as regulatory lifecycle management and interactions with CMOs, external partners, and health authorities.

This is an exciting opportunity to join a dynamic team and shape the future of regulatory operations at Macure Pharma.



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