Senior Regulatory Operations Specialist I
Job Description
- 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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