Regulatory Affairs Senior Specilist

Kenvue

Shanghai, China
Fully onsite
Develop problem-solving strategies for project teams
Ensure product compliance and high-quality submissions
Establish feasible registration pathways for otc and medical devices
Kenvue is seeking a Regulatory Affairs Senior Specialist in Shanghai to drive compliance and strategic insights for product registrations in the health sector. The role involves developing regulatory strategies, managing submissions, and collaborating with internal and external stakeholders to ensure efficient market entry

Job Summary

  • Kenvue is a global company built on over a century of heritage rooted in science, caring for millions of people daily.
  • The role involves developing problem-solving strategies to ensure product compliance and deliver high-quality submissions for new product development and lifecycle management projects.
  • Candidates will establish and maintain strong connections with Chinese regulatory authorities like the NMPA and CDE to ensure effective product registrations.

Matching Summary

Match Score: 85

Kenvue is seeking a Regulatory Affairs Senior Specialist in Shanghai to drive compliance and strategic insights for product registrations in the health sector. The role involves developing regulatory strategies, managing submissions, and collaborating with internal and external stakeholders to ensure efficient market entry.

Skills & Requirements

Must-have

  • Develop problem-solving strategies for project teams
  • Ensure product compliance and high-quality submissions
  • Establish feasible registration pathways for OTC and medical devices
  • Manage end-to-end regulatory dossier process
  • Maintain connections with NMPA and CDE authorities

Nice-to-have

  • Provide strategic regulatory insights in Big-health industry
  • Partner with internal business stakeholders globally
  • Shape favorable regulatory environment through external engagement
  • Drive innovation in self-care product portfolio

Key Requirements

  • Experience with ANDA/NDA submissions
  • Knowledge of variations and renewals processes
  • Understanding of OTC, Medical Device, and Health Food regulations
  • Ability to mitigate project risks upfront

Work Rights

Not specified

Tailored Resume

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