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

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