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 submission content in accordance with regulatory requirements and internal procedures.
Coordinate the collection of required documentation from internal and external stakeholders.
Order Manufacturer's Summary Records (MSRs)



from manufacturers and initiate legalization requests where required.
Ensure submission content aligns with the agreed regulatory strategy and available Chemistry, Manufacturing and Controls (CMC) documentation, where applicable.
Manage submission content within SCP.
Oversee the document lifecycle, including document matching, review, approval, version control, and document locking.
Ensure submission packages are complete, compliant, and submission-ready.
Stakeholder Collaboration
Partner with Local Operating Companies (LOCs), CMC teams, manufacturing sites, and other cross-functional stakeholders to clarify submission requirements and obtain necessary documentation.
Proactively identify, escalate, and resolve issues that could impact submission quality, compliance, or delivery timelines.
Communicate submission status and key milestones to relevant stakeholders.
Quality and Compliance
Review submission documentation for accuracy, comp

📌 Regulatory Specialist (Mumbai)
🏢 G&L Scientific
📍 Mumbai