Our client is a renowned international pharmaceutical company. They are now seeking strong RA professional to join their team in Hong Kong.

Responsibilities

• Responsible for all the regulatory compliance of their key products in Hong Kong and Macau.
  
• Review and approve product labelling and marketing materials for regulatory compliance.
• Participate in the development, execution and maintenance of the regulatory procedures.
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
• Tracks the status of applications under regulatory review and provides updates to all stakeholders.
• Tracks and maintains files on annual licenses, registrations and listings.
• Maintains systems to track, manage and report product-associated events.
• Monitors the regulatory environment and maintains information resources.
• Tracks product complaints, events and recalls.
• Co-ordinate with other internal departments to facilitate product development and sales.

Requirements

• At least 5+ years of experience working in regulatory affairs field in pharmaceutical sector.
• Have solid experience in global/ regional regulatory management.
• Familiar with the regulatory and trade compliance.
• Good communication and interpersonal skills.
• Good command in English and Mandarin.

If you are interested, please click the "Apply" button below or call 2506 9011 for Maggie Lai for a private discussion.