Regulatory Affairs Executive

JOB DESCRIPTION:

Primary Job Function:

• Label Change Management:

• Review and approve Chinese Package Insert and Label Change as per Chinese regulation and Abbott policy requirements, and communicate with the sourceand/or Global Label Center to make sure all changes implementation correctlyand timely,and ensure no delay for market supply due to Label Change.
• Communicate, plan, prioritize and deliver labeling documents according to company targets and submission requirements, initiate and approvelabel/artwork change in Agile system (Global Label Change system) .

• Establish and update internal SOPs to fulfillcompliance with requirements, and conduct the training accordingly. Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient way.
• Manage the regulatory and compliance systems such as DARIUS, SolTRAQs, ISOtrain etc. to give full support to the team.
• Collect and analyze related regulatory regulations/gudelines to give interpretation.
• Assist supervisor to complete urgent assignments as required in a timely manner.
• Other job related tasks as assigned

Core Job Responsibilities:

• Label Change Management:

• Review and approve Chinese Package Insert and Label Change as per Chinese regulation and Abbott policy requirements, and communicate with the sourceand/or Global Label Center to make sure all changes implementation correctlyand timely, and ensure no delay for market supply due to Label Change.
• Communicate, plan, prioritize and deliver labeling documents according to company targets and submission requirements, initiate and approve label/artwork change in Agile system (Global Label Change system) .

• Establish and update internal SOPs to fulfill compliance with requirements, and conduct the training accordingly. Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient way.
• Manage the regulatory and compliance systems such as DARIUS, SolTRAQs, ISOtrain etc. to give full support to the team.
• Collect and analyze related regulatory regulations/gudelines to give interpretation.
• Assist supervisor to complete urgent assignments as required in a timely manner.
• Other job related tasks as assigned

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

EPD Established Pharma

LOCATION:

China > Beijing : Canway Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable