Regulatory Specialist
2 weeks ago
Responsible to work with China sales Manager and other regional sales Managers to get approval on new site qualifications of China plant by Global pharma customers.
Creating & maintain the version control of all Pharma regulatory & Quality documents, review and maintain the plant raw data, contract lab results for sites mentioned.
Responsible to maintain the Trackers pertaining Risk contaminant reports, stability studies, registration filing status, Monthly Regulatory reports for sites mentioned.
Collect, review, and share the China plants documents to Pharma regulatory team to support EIP compilations.
Key Interfaces:
Internal:
- China Pharma Sales Manager, Regional Pharma sales Managers & team, Global Marketing, Global Technical and Ingredion China plant (Shanghai)
External:
- China Health authority, IPEC China, Customer's technical team and China Industrial forums
Yes, Within Country
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