Regulatory strategy establishment for new vaccines and the regulatory strategy implementation by CTA / NDA submission / approval.
- Work with GRA and across project team to develop and implement the regulatory strategy of the responsible projects, aligned with global strategy and regional business strategy. (Dossier preparation, gap assessment, regulatory pathway and timelines, RA compliance, Implication of the findings on the deal terms, ways to mitigate identified risks, implications on cost / time etc.)
- Regulatory supports for the related submissions in China region
- Collaborate with related functiona at corporate, IA and project team to support the regulatory activities in China region.
- Effective interaction with Health Autorities.
- Lead the cooperative projects related to shaping of registration regulatory environment.
- Lead and coordinate the HA interaction and cross-functional discussion & contribution.
- Provide RA inputs
- Move forward the projects in agreed timetable.
- Provide RA supports on vaccine China business
- Work with related functions in China to provide RA support on business timely.
- Update key changes in regulations and their implications
- Inputs for strategic projects on RA regulations, requirements, trends.
- Ensure regulatory compliance and work in compliance way
Job Family Group: Regulatory Affairs - Center of Expertise
