Digital Regulatory Operations Lead

4 days ago


Copenhagen, Copenhagen, Denmark Macure Pharma Full time

Mature, niche hospital products company focusing on pharmaceutical manufacturing seeks a skilled Regulatory Publisher & Submission Manager.

Responsibilities include:

  • Compiling, formatting, and validating regulatory submissions in eCTD.
  • Developing and maintaining 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.
  • Implementing and optimizing our digital document management system to streamline workflows and ensure operational excellence.

The ideal candidate will have a proactive mindset, an eye for efficiency improvements, and a passion for regulatory processes.



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