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Purpose:
The Associate/Manager, Regulatory Delivery Excellence (RDE), China Regulatory Affairs is responsible for activities related to the regulatory registration management processes and submission preparation support. The scope of the work includes the clinical trial permit (CTP) applications through withdrawal of the marketing applications.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Manage the registration process by providing expertise in submission regulations, guidance and technical contents. Ensure compliance with all applicable regulations and internal quality systems.
Develop submission plans for assigned projects:
Partner with Regulatory TA & CMC team members, vendors and other contributing functions to develop submission plans, including dossier lists, timelines etc.
Collaborate with the related functions to ensure effective execution of the submission plan.
Manage RIM-related activities and collaborate with GRA RD&E team to support the submission plan
Escalate issues that may impact submissions and timelines.
Support regulatory TA & CMC teams on submission related activities:
Arrange translations and manage the quality checks of translated materials.
contribute local Module 1 documents to RIM content plans for new MAAs, Line extensions and new indications
Author administrative documents based on guidance from Regulatory scientists
Perform document formatting and manage the quality checks
Compile submission dossiers according to the submission plan
Execute QC testing-related activities, including material ordering, contract execution, and vendor communication etc.
Serve as the Subject Matter Expert (SME) for regulatory business processes and how those are executed in the Veeva Vault RIM system to ensure consistency of process execution and data.
Input and maintain data in China/global IT system, e.g. RIM, China submission archive and maintenance platform, etc.Develop collaborative relationships with personnel in the related functions (e.g. CRP, SC, GPS, Stats, CDTL, CSM, GRA RD&E,etc.) to effectively execute the registration plan.
Leverage internal and external forums to continue to develop and share regulatory, drug development, and therapeutic expertise.
Minimum Qualification Requirements:
At least bachelor’s degree in pharmaceutical or chemical/biopharmaceutical sciences
At least 2 year experience in drug regulatory affairs or drug development for manager (P2)
Preferable to experience in leading pharmaceutical company
Good skill on English writing, speaking and listening
Good skill on computer operation
Self-motivated
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