Job DescriptionPrimary Function of Position This position will partner with the in-country RA team as well as the Product Localization Engineering (PLE) and other cross-functional supporting teams, ensuring that the company's regulatory affairs activities are conducted in accordance with company policies and in compliance with the latest relevant regulations and standards. This ensures regulatory compliance with China requirements for all relevant aspects throughout the lifecycle of the products subject to the China market. Additional responsibilities include maintaining regulatory filings and licenses, and providing support to the cross-functional team for assigned tasks pertaining to pre-market applications and/or post-market regulatory compliance.
Essential Job Duties Act as the RA project lead with minimum oversight when supporting China product registration applications, covering both 'the RA Lead at ISI side' and 'the RA Project Manager'. Responsibilities include:Coordinating and assisting in regulatory/clinical strategy development and timeline establishment.Collaborating with JVRA to provide explanations to ISI supportive teams on China regulatory requirements to ensure deliverables prepared for NMPA submission are compliant.Coordinating and prioritizing tasks assigned with oversight.Supporting activities pertaining to the Product Technical Requirement (PTR) draft and type testing, including test sample arrangement.Writing and reviewing certain sections of the dossier.Coordinating with JVRA and ISI stakeholders to provide supportive information required for regulator communications (consultation, workshop, etc.).Creating and maintaining a Tracker to ensure deliverables required for submission or deficiency response are comprehensively captured and updated timely.Managing the maintenance of the China Regulatory Project Executive Summary for responsible projects.Demonstrating flexibility as priorities change as a member of the China/HK RAQA group.Supporting department goals and continuous improvement initiatives.Reviewing and approving GRAs.Articulating local regulatory requirements to the organization as needed and assisting in developing or revising internal procedures to ensure continuous compliance with all applicable China regulatory requirements.Supporting internal and external audits related to China compliance.Providing support in China localization projects when needed (manufacturing transfer, etc.).Working with the post-market team in support of China Periodic Safety Update Reports (PSUR) generation.Providing working-level guidance to contractors for completing assigned tasks.
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