Found Description
Submission Management Specialist
This role can worked from Mumbai or Hyderabad
The Submission Management Specialist is responsible for the end-to-end coordination, preparation, quality review, and finalization of regulatory submissions. This role ensures submission packages are complete, compliant, and delivered within agreed timelines by collaborating with cross-functional stakeholders and managing submission documentation throughout its lifecycle.
Key Responsibilities
Submission Management
- Assign regulatory submissions (HAQ) and initiate submission activities.
- Review submission requests to ensure completeness and confirm the submission scope.
- Maintain accurate submission records and update submission tracking systems throughout the submission lifecycle.
Submission Content Management
- Prepare, author, and manage submissio...