Job Description Submission Management Specialist
n This role can worked from Mumbai or Hyderabad
n 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.
n Key Responsibilities
n Submission Management
n n Assign regulatory submissions (HAQ) and initiate submission activities.
n Review submission requests to ensure completeness and confirm the submission scope.
n Maintain accurate submission records and update submission tracking systems throughout the submission lifecycle.
n n Submission Content Management
n n Prepare, author, and manage submission content in accordance with regulatory requirements and internal procedures.
n Coordinate the collection of required documentation from internal and external stakeholders.
n Order Manufacturer's Summary Records (MSRs) from manufacturers and initiate legalization requests where required.
n Ensure submission content aligns with the agreed regulatory strategy and available Chemistry, Manufacturing and Controls (CMC) documentation, where applicable.
n Manage submission content within SCP.
n Oversee the document lifecycle, including document matching, review, approval, version control, and document locking.
n Ensure submission packages are complete, compliant, and submission-ready.
n n Stakeholder Collaboration




n n Partner with Local Operating Companies (LOCs), CMC teams, manufacturing sites, and other cross-functional stakeholders to clarify submission requirements and obtain necessary documentation.
n Proactively identify, escalate, and resolve issues that could impact submission quality, compliance, or delivery timelines.
n Communicate submission status and key milestones to relevant stakeholders.
n n Quality and Compliance
n n Review submission documentation for accuracy, completeness, consistency, and regulatory compliance.
n Coordinate document review cycles and incorporate stakeholder feedback and required revisions.
n Ensure submissions meet internal quality standards and applicable regulatory requirements before finalization.
n n Finalization and Handover
n n Finalize submission packages and hand them over to the Local Operating Company (LOC) for dispatch to the relevant Health Authority.
n Ensure all submission documentation is accurately tracked, archived, and maintained in accordance with company procedures and regulatory requirements.
n n Key Competencies
n n Strong knowledge of regulatory submission processes and document management.
n Excellent organizational and project coordination skills.
n Solid attention to detail and commitment to quality and compliance.
n Effective stakeholder management and cross-functional collaboration skills.
n Excellent written and verbal communication skills.
n Ability to manage multiple priorities and meet tight deadlines.
n Proficiency with submission and document management systems (e.g., SCP) and Microsoft Office applications.
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📌 Regulatory Specialist (Raigarh)
🏢 G&L Scientific
📍 Raigarh