Maintain up-to-date records and databases of regulatory files, product specifications and approval statuses.
Maintain an internal filing system to track submission statuses.
Follow up on the product registration progress, communicate with the government and relevant industry departments on registration matters, coordinate and deal with problems in the registration process, and ensure that registration approval documents are obtained on time.
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Regulatory Compliance & Inspection Readiness: Ensure all Affiliate regulatory activities comply with Roche global standards and local regulations, maintain current knowledge of practices and standards, and ensure the Affiliate is prepared for regulatory inspections and audits
Leadership and Team Management: As the senior team member, set the team's strategy and priorities, allocate resources, provide coaching and mentorship, and assist in recruiting and retaining talent
Regulatory Intelligence and Policy Shaping: Own the gathering and dissemination of regulatory intelligence for the Affiliate, and actively shape the regulatory environment through leadership roles in industry associations
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