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Senior Manager/Associate Director Regulatory Affairs

Chef i Storkøbenhavn

Senior Manager/Associate Director Regulatory Affairs

Join an entrepreneurial and fast-growing company where skilled, agile and highly resourceful professionals can truly make their mark.

As Senior Manager/Associate Director Regulatory Affairs at Ascendis Pharma you will be a part of the different teams driving Ascendis’ development projects further. You will be a key member of the Regulatory Affairs team and provide effective support to the organization to ensure the best development programs for your designated projects. You will be responsible for operational regulatory input across CMC, Non-clinical and Clinical in collaboration with the rest of the RA team.

The position will report to the Senior Director, Regulatory Affairs, DK.

Your main tasks are:

  • Support of INDs and clinical trial applications, NDA/BLAs, MAA and other regulatory documents as needed
  • Collaborate in project teams with e.g. scientific advice preparation, orphan drug designation applications and paediatric investigation plans including writing and supporting regulatory communications
  • Contribute to establishing and administering internal regulatory policies and procedures to achieve best practices work processes including writing of SOPs
  • Stay abreast of newly...