Senior Specialist - Submission Management
Job Description
Your Role:
The Senior Regulatory Submission Manager is responsible for overseeing the planning, compilation, publishing, and dispatch of regulatory submissions to Health Authorities throughout the product lifecycle. This role ensures compliance with regulatory standards and optimizes submission processes to facilitate timely approvals.
- Manage and execute submission planning and execution across the product lifecycle.
- Create and maintain submission packages and content plans.
- Ensure the accuracy and completeness of regulatory data in Veeva Vault RIM.
- Track Health Authority queries, document approvals, and registration details.Publish and validate eCTD outputs to ensure successful submission.Monitor compliance with submission standards and processes.Collaborate with international cross-functional teams to resolve issues and optimize workflows.
- Provide guidance and oversight for submission management and publishing.
- Serve as a subject matter expert on eCTD and Veeva Vault RIM.Enhance submission templates and processes to meet evolving Health Authority requirements.
Who You Are:
- Minimum 7-13 years in Regulatory Submission Management.
- Master’s Degree in Life Sciences, Medical, PharmD, or equivalent.