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 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

• Strong 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.