Job DescriptionSubmission Management Specialist

NThis role can worked fromMumbai or Hyderabad

NThe Submission ManagementSpecialist 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.

NKey Responsibilities

nSubmission Management

N

n
- Assign regulatorysubmissions (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

nSubmission ContentManagement

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

nStakeholder 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

nQuality and Compliance

N

n
- Review submissiondocumentation for accuracy, completeness, consistency, and regulatory compliance.
N
- Coordinate document review cycles and incorporate stakeholder feedback and required revisions.
N
- Ensure submissions meetinternal quality standards and applicable regulatory requirements before finalization.
N

nFinalization 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

nKey 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.
N

📌 Regulatory Specialist (Alibag)
🏢 gu0026l scientific
📍 Alibag