Regulatory Specialist

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...