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.
Learn more about our EEO \& Accommodations request here .