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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