Senior Regulatory Affairs Manager

2 days ago


Copenhagen, Copenhagen, Denmark Macure Pharma Full time

We are seeking a highly experienced Regulatory Publisher & Submission Manager to join our Regulatory Affairs Team in Copenhagen or Malta.

As a key member of our team, you will be responsible for:

  • Regulatory publishing: compiling, formatting, and validating regulatory submissions in eCTD.
  • System implementation: playing a key role in the implementation of our new Submission Publishing Tool and ensuring its successful integration.
  • Process optimization: identifying opportunities to streamline workflows and drive efficiency within Regulatory Affairs.
  • Regulatory affairs: supporting submission processes for National, MRP, and DCP procedures, as well as regulatory lifecycle management and interactions with CMOs, external partners, and health authorities.

If you have experience in implementing or working with EDMS systems, your expertise will be highly valued in this role.



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