Hengrui USA is hiring : Regulatory Publishing Specialist — 恒瑞-全球精英计划 in Princeton

HR Management Trainee | Talent Acquisition at Hengrui Pharmaceuticals

Job Responsibilities

• Assist Regulatory Affairs personnel in the preparation and submission of INDs / BLAs / NDAs and life cycle management.
• Electronically format and publish electronic documents; builds Regulatory submission deliverables. Ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
• Provides guidance on good documentation and submission practices to project teams.
• Provides input on submission timelines and eCTD content plans.
• Reviews documents to ensure compliance with electronic requirements.
• Support archiving (categorizing and classifying information) of Regulatory records pertaining to multiple Regulatory Applications (e.g., IND, BLA, MAA, Annual Reports, AEs), maintaining Regulatory Application indexes, tracking of regulatory submission documents, and special projects as needed.
• Identifies and communicates regulatory system enhancement needs or technical issues.
• Assist with maintaining Document Authoring Template Library and Template development.
• Contribute to miscellaneous regulatory operational activities and special projects as assigned.

Qualifications

Seniority level

Employment type

Job function

Industries

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