Regulatory Affairs Sr Specialist

Job Summary
The Regulatory Affairs Specialist will support Great China Regulatory Affairs with implementation of the appropriate licensing, registration, regulatory compliance for HCB products that are being or going to be sold in Great China market.
Responsibilities
1. New Product Registration & Maintenance for Existing Registration
a. Study registration feasibility to support marketing plans
b. Organize all the required documents in cooperation with IRD, Asia PD and 3rd party institutes for HCB portfolio in Great China market
c. Manage document packages for Regulatory submissions and application for product registration / amendment / extension
2. Assuring compliance of products with existing legislations under CFDA, EPA etc.
a. Keep track of up-to-date regulatory requirements for products so as to comply with legal requirements, local authorities and regulations, as well as Henkel Standards
b. Provides regulatory inputs during the artwork review process to ensure correctness of labeling
c. Support innovation project on regulatory compliance and provide regulatory assessment on efficacy and claims
d. Align and take action with global team, LMU and Asia PD for draft of new regulations or standards
e. Provide support in case of Authorities’ inspections/discussion
Accountabilities (Time in %)
1. New Product Registration & Maintenance for Existing Registration (50%)
a. Study registration feasibility to support marketing plans (5%)
b. Organize all the required documents in cooperation with IRD, Asia PD and 3rd party institutes for HCB portfolio in Great China market (20%)
c. Manage document packages for Regulatory submissions and application for product registration / amendment / extension (25%)
2. Assuring compliance of products with existing legislations under CFDA, EPA etc. (50%)
a. Keep track of up-to-date regulatory requirements for products so as to comply with legal requirements, local authorities and regulations, as well as Henkel Standards (10%)
b. Provides regulatory inputs during the artwork review process to ensure correctness of labeling (15%)
c. Support innovation project on regulatory compliance and provide regulatory assessment on efficacy and claims (15%)
d. Align and take action with global team, LMU and Asia PD for draft of new regulations or standards (5%)
e. Provide support in case of Authorities’ inspections/discussion(5%)