Regulatory Compliance Lead

17 hours ago


Copenhagen, Copenhagen, Denmark Macure Pharma Full time

We are looking for a Regulatory Compliance Lead to join our team at Macure Pharma. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines. Your expertise in eCTD publishing and regulatory submission workflows will be instrumental in shaping our digital regulatory processes.

Responsibilities:
  • Leading the development and implementation of SOPs to ensure regulatory compliance and operational excellence.
  • Compiling and formatting regulatory submissions in eCTD format, ensuring accuracy and compliance.
  • Implementing and optimizing our new Publishing Tool, leveraging your knowledge of EDMS systems and workflow optimization techniques.
  • 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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