Connecting...

Regulatory Affairs - Submissions Manager

Job description

Job Responsibilities include;

  • The Submissions Manager will project manage tasks related to the compilation/ publishing of global Regulatory submissions.
  • They will create and manage cross-functional timelines for global submissions with consideration of key interdependencies
  • The Submissions Manager will lead a global publishing team in the context of a given submission
  • Responsible for the management of compliant global submissions being delivered on time.
  • Responsible for technical interactions with global HA.
  • Submission Manager lead of Global Regulatory Team.
  • Standardizing best practices for management of regulatory submissions to ensure consistency.
  • Responsible for ensuring processes related to eCTD readiness and authoring submission documentation are adhered to.

Job Requirements;

  • The Submissions Manager will have a relevant Degree with 5 years expereince in pharmaceutical regulatory affairs.
  • At least 3 of those years should have been working within a submission management function with knowledge/ expereince of global submissions.

For further information on this role please reach out today amorgan@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.