Context & challenge
- Global Life-cycle management to provide efficiency and cost saving for the client, including standardized submission processes and local regulatory intelligence.
- Initial Filing: Support to the strategic roll out plan and speed up the Go-To-Market. We put in place a systematic approach to predict project risks related to targeted submission dates and approved budget.
- Regulatory Operations: ensure US/EU/Asian operations and expertise with the objective to support business continuity and absorb high volume for strategic projects related to new submission or new tool. RIM completion, Publishing, Labeling.