Regulatory Expert / Sr. Specialist

Roche UK

Nmpa registration regulations expertise
5+ years medical regulatory affairs experience
Ivd product r&d or regulatory background
The role involves preparing registration dossiers for submission to the NMPA to obtain approval according to a specific registration plan

Job Summary

  • The role involves preparing registration dossiers for submission to the NMPA to obtain approval according to a specific registration plan.
  • Candidates must ensure the accuracy and truthfulness of all documents while maintaining relationships with testing centers and global teams.
  • The position requires proactive identification of regulatory risks and the development of innovative strategies to accelerate product launches.

Matching Summary

The role involves preparing registration dossiers for submission to the NMPA to obtain approval according to a specific registration plan.

Skills & Requirements

Must-have

  • NMPA registration regulations expertise
  • 5+ years medical regulatory affairs experience
  • IVD product R&D or regulatory background
  • Fluent English communication skills
  • MS-Office operation proficiency

Nice-to-have

  • Strong cross-functional collaboration abilities
  • Experience influencing national standard formulation
  • Proactive risk assessment and mitigation skills
  • Ability to work under pressure
  • Negotiation and social activity skills

Key Requirements

  • Bachelor degree in medicine, bioengineering, pharmacy, or related field
  • Minimum 5 years experience in medical regulatory affairs
  • Expertise in NMPA registration policies and guidelines
  • Background in IVD products or regulatory processes preferred

Work Rights

Not specified

Tailored Resume

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