RA Specialist - Listed Medical Company
Page Personnel
Hong Kong Island, Hong Kong
6天前

About Our Client

Our client is a worldwide market leader in the health care industry with an extensive portfolio of medical products. In order to facilitate the growth of their market share, they are now looking for an experienced Regulatory Specialist talent to join their winning team.

Job Description

  • Support the development and licensure of regulatory strategies for assigned products
  • Ensure timely communication of regulatory strategy and plans to team members and line management
  • Plan & coordinate regulatory submissions including meetings with health authorities, INDs, Annual Reports and routine correspondence
  • Provide critical review of all documentation supporting regulatory applications
  • Provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance
  • Interact with company partners and consultants for various regulatory matters as needed
  • The Successful Applicant

  • University graduate in Science, Medical or Pharmaceutical related field
  • At least 3 years' regulatory affairs / quality affairs experience with pharmaceutical drugs or medical devices
  • Excellent communication and interpersonal skills
  • Able to work independently with good planning and problem solving skills
  • Fluency in spoken and written English and Chinese
  • What's on Offer

  • 13 months' competitive salary package
  • Performance bonus
  • On the job training
  • Team working culture
  • Medical Coverage
  • Dental insurance
  • 5-day Work Week
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