Senior Specialist Submission Management

Responsibilities

• Manage and execute planning, compilation, and dispatch of submissions to Health Authorities during the application lifecycle.
• Create and update submission packages and Submission Content Plans for submissions to Health Authorities.
• Create and update records in Regulatory Information Management system and ensure submissions are documented properly in regulatory systems including tracking of HA questions and documentation of approval and registration details in Veeva Vault RIM.
• Liaise and follow-up with RD functions to provide required submission-relevant documents on time and in submission ready format.
• Publish and perform quality checks, validate eCTD output, and submit eCTDs through supported HA gateway.
• Collaborate with submission management and publishing vendors, resolve, or coordinate any queries, and perform spot checks on output.
• Functional oversight of vendors for submission management and publishing.
• Crisis intervention in case of vendor issues to avoid impact on quality or project timelines.
• Key contact for eCTD and Publishing expertise.
• Act as power-user for submission applications (Veeva Vault RIM).
• Author cover letter and application forms in close cooperation with the License Manager or Regulatory Lead.
• Monitor compliance with submission standards and submission process (internal external).
• Manage and improve quality of submission standards and templates for submission-relevant documents ensuring compliance with HA requirements.

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