Senior Regulatory Operations Specialist I

• Prepare compile & review product quality (CMC) & other regulatory documents to support product development or submissions to various countries across the world for product registrations or post approval life cycle maintenance.

• Create and/or revise raw material and packaging specifications and other associated documents.
• Coordinate and interact with cross functional teams/departments for evaluation/impact assessment of change control review implementation strategy and required documentation governing the change and manage OOS OOT or other product related changes.
• Support Financial Data Management Business Plan file creation and maintenance Supplier data management and PO creation as required.
• Support for creation and update of global labeling documents QC and other associated activities for the labeling projects
• Support stability data evaluation & report preparation dissolution profile evaluation etc.
• Perform literature survey and preparing of various regulatory documents in support of excipients APIs and/or drug products.
• Coordinate with stakeholders to understand and support import license requirements investigation report drafting record management and document coordination with internal and external department.
• Responsible for specifications setting/justification ensuring the Quality level for Laboratory support perform Computerized System Validation (CSV) and upgradation of existing systems/software.
• Seek guidance from other team members and manager as needed and keep up to date knowledge of various regulatory guidelines required for pharmaceutical product registration and product life cycle maintenance.
• Implement use of consistent efficient and quality processes to meet timelines and deliverables according to regulatory requirements standard operating procedures and maintain a culture of high customer services.
• Japanese language expert (minimum JLPT N3 certified professional) with experience in Japanese business email and client communication.
• Support Japanese regulatory and supplier correspondence translations (Japanese English) and coordination with RA teams.

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