Regulatory Expert / Sr. Specialist

Regulatory Affairs Specialist

At Roche, we are dedicated to advancing science and ensuring global access to healthcare. We are seeking a professional to manage registration dossiers, ensure regulatory compliance, and maintain strong relationships with NMPA testing centers to support our product launch strategies.

Responsibilities

• Prepare and submit registration dossiers to NMPA to meet project timelines.
• Ensure the accuracy and integrity of all registration documentation and maintain records in company systems.
• Collaborate with global teams, internal departments, and external stakeholders to provide regulatory support.
• Participate in the formulation of national and industrial standards and provide feedback on regulatory guidelines.
• Conduct risk assessments, develop mitigation plans, and propose innovative registration strategies to accelerate product launches.
• Manage stakeholder expectations and ensure all business activities comply with company policies and safety standards.

Requirements

• Bachelor’s degree or higher in medicine, bioengineering, clinical medicine, biochemistry, or pharmacy.
• Minimum of 5 years of experience in medical regulatory affairs, preferably with a background in IVD product R&D or regulation.
• Expertise in NMPA registration regulations, policies, and relevant standards.
• Fluent in English (listening, speaking, reading, and writing) and proficient in MS Office.
• Strong interpersonal, communication, and negotiation skills with the ability to work independently and under pressure.
• Demonstrated commitment to Roche values of Integrity, Courage, and Passion.