Roche is seeking a Regulatory Expert/Sr. Specialist with expertise in NMPA registration regulations to manage the preparation and submission of registration dossiers. The ideal candidate should have at least five years of experience in medical regulatory affairs, strong interpersonal skills, and a collaborative mindset
Job Summary
The role involves preparing and submitting registration dossiers to the NMPA to ensure timely product approval and compliance with company SOPs.
Candidates will actively participate in discussions regarding national standards and guidelines while collaborating with global teams on PTR and type testing.
Roche fosters a culture of personal expression and genuine connections where every voice matters in the mission to prevent, stop, and cure diseases.
Matching Summary
Match Score: 85
Roche is seeking a Regulatory Expert/Sr. Specialist with expertise in NMPA registration regulations to manage the preparation and submission of registration dossiers. The ideal candidate should have at least five years of experience in medical regulatory affairs, strong interpersonal skills, and a collaborative mindset.
Skills & Requirements
Must-have
NMPA registration regulations expertise
IVD product regulatory experience
Registration dossier preparation and accuracy
Stakeholder management with testing centers
Risk assessment and mitigation strategies
Nice-to-have
Experience in national standard formulation
Cross-functional collaboration skills
Innovative registration strategy development
Strong negotiation and interpersonal 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 IVD standards