Responsibilities may include the following and other duties may be assigned:

• Becomes an expert in Global regulations regarding changes purposes.
• Assesses and provides feedback whether there is an impact of Regulatory Assessment Change. If more information is required the RAC could be reviewed with the respective Regulatory Affairs Specialist
• Works closely with the Reg Ops Specialist to build evidences to submit in the CABs
• Monitors and addresses appropriate stakeholders such as Operating Units and RACs originators in order to clarify change information (if needed)
• Be available to support audits if it is needed, ensuring regulatory efficiency by maximizing the team's efforts, ensuring the execution of regulatory strategies that will impact the entire RA function in SSC.
• Follow up RACs (Regulatory Assessment Changes) that need submission and prior approval. 
• Provides the information to create statistical reports as requested per their RA Manager.

Required Knowledge and Experience:

• Bachelor’s degree
• One year of relevant experience in regulatory affairs or related areas
• Fluent English level (Reading/Writing/Comprehension)
• Strong organizational skills and effective time management skills
• Document interpretation, queries and workflow skills.
• Flexible with changing priorities and works well under pressure in a fast paced, dynamic environment
• Knowledge in MS Office,  Excel and proficient in software use.
• Experience with SAP and GTS is advantageous
• Experience with PLM use (Product Life Management tools e.g. Agile)
• Ability to work in matrix structured organization.
• Able to work in a Hybrid environment