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, completeness, consistency, and regulatory compliance.
- Coordinate document review cycles and incorporate stakeholder feedback and required revisions.
- Ensure submissions meet internal quality standards and applicable regulatory requirements before finalization. Finalization and Handover - Finalize submission packages and hand them over to the Local Operating Company (LOC) for dispatch to the relevant Health Authority.
- Ensure all submission documentation is accurately tracked, archived, and maintained in accordance with company procedures and regulatory requirements. Key Competencies - Solid knowledge of regulatory submission processes and document management.
- Excellent organizational and project coordination skills.
- Strong attention to detail and commitment to quality and compliance.
- Effective stakeholder management and cross-functional collaboration skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities and meet tight deadlines.
- Proficiency with submission and document management systems (e.G., SCP) and Microsoft Office applications.

📌 Regulatory Specialist (India)
🏢 gu0026l scientific
📍 India