Regulatory Expert / Sr. Specialist

About the Role Roche is seeking a Regulatory Expert / Senior Specialist to lead the preparation and submission of regulatory dossiers with NMPA, ensuring accuracy and compliance with Roche SOPs throughout the lifecycle. This role requires collaboration across global teams and internal departments to accelerate product registrations while managing regulatory risks.

What You'll Do

• Prepare the registration dossier to submit to NMPA and obtain approvals to meet the registration plan.
• Ensure the accuracy and truthfulness of the registration dossiers and maintain all submission and approved dossiers in related IT systems, SharePoint, V drive, and notify stakeholders per SOP requirements.
• Complete related payment procedures in systems on time; place orders for QC testing (including FOC for QC testing).
• Actively participate in discussions and verifications of national standards or panel verifications or national/industrial standard discussions; guide and influence formulation of standards.
• Work with global teams to draft PTR and complete type testing on time if needed.
• Actively involve in regulation guidance discussions; provide feedback to authorities aligned with Roche Regulatory Strategy; guide and influence guideline formation.
• As a member of RD, provide active regulatory support to internal departments as needed.
• Proactively manage daily tasks; keep records; maintain filing and ensure documents are updated on time per requirements.
• Collaborate in cross-functional teams with diverse perspectives; proactively resolve issues and build effective networks.
• Proactively identify and assess regulatory changes and contribute ideas on key project registration strategies.
• Conduct risk assessment and mitigation planning across product lifecycle; anticipate regulatory risks and propose mitigation plans.
• Propose innovative registration strategies aligned with regulations and available resources to accelerate product launch.
• Manage stakeholder expectations from the business analysis perspective; facilitate project completion within time, budget, and compliance constraints.
• Comply with Roche policies including Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.
• Perform other tasks assigned by line manager as needed.