Regulatory Affairs Manager
AbbottChina - shanghaiUpdate time: July 12,2018
Job Description

Major Responsibilities:

• Communicate regulatory and quality governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements.

• Implement policies, procedures, practices for Regulatory Affairs

• Handle RA projects independently.

• Closely communicate with the Global RA and local business partner to get necessary information for product registration.

• Act as company representative with governmental agencies to make registration problems encountered be effectively resolved.

• Establish and maintain good communication and relationship with related authority and industry association.

• Manage multiple, sometimes conflicting priorities

• Implement and manage labeling review activities to meet commercial launch date. 

• Present to upper management at required intervals and effectively communicate successes and challenges.

• Provide relevant regulatory compliance support to other functional groups.

• Review advertisement and promotional materials as required.

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