Regulatory Affairs Specialist NMPA​/CFDA

Primary Function of Position

This RA Specialist will play a key role in managing China RA regulatory intelligence, working closely with the in-country RA team to facilitate China regulation and standard assessment. This position will also collaborate with the local RA team, the Product Localization Engineering (PLE), and other cross-functional supporting teams to ensure the company's regulatory affairs activities are conducted in accordance with company policies and in compliance with the latest relevant regulations and standards.

The goal is to maintain regulatory compliance across all relevant aspects of the product lifecycle for China and Hong Kong. Additional responsibilities include regulatory operation activities to support the Approved Product List (APL) process, and product shipping block (RA Block) and release processes. The RA Specialist will also provide cross-functional support and manage assigned tasks pertaining to pre-market applications and/or post-market regulatory compliances.

Essential Job Duties

• Regulatory Intelligence Coordination
  • Serve as the Point of Contact (PoC) for Regulatory Intelligence, focusing on Regulations and Standards Assessment (RSA) for China RAQA department.
  • Collaborate with the in-country RA team to monitor, maintain, and communicate updates on China Regulations & Standards applicable to ISI products.
  • Work with the ISI RSM team to update standards and regulations in Trackwise, engaging with ISI SMEs for RSA completion and implementation as needed.
  • Conduct gap assessment on China regulatory changes to support strategic decision-making.
  • Maintain a knowledge base of regulatory affairs guidelines in China and Hong Kong, providing input on updated regulations and standards as needed.
• Regulatory submissions and GRA (Global Regulatory Assessment)
  • Coordinate and prepare regulatory filing/submission documents and work with in-country RA team for submissions to regulatory authorities in China & Hong Kong.
  • Provide regulatory guidance on China and Hong Kong regulatory requirements for new product development and product change projects, ensure compliance with submission deliverables.
  • Maintain regulatory clearances and approvals, including necessary filings, archival, and communications.
  • Conduct global regulatory assessment (GRA) for Hong Kong in partnership with the in-country RA team and prepare the associated change notifications and registrations to support supply continuity.
• Regulatory Operations
  • Support the post-market team in preparing the China Periodic Safety Update Reports (PSUR) and annual inspection report.
  • Support the Approved Product List (APL) process.
  • Assist in product shipping block (RA Block) and release processes.
  • Develop and maintain departmental procedures and database, contributing to continuous improvement initiatives as needed.
  • Coordinate recall or market withdrawal activities as needed.