Regulatory Affairs Executive
Hugh Source (International) LtdTsimshatsui EastUpdate time: August 28,2019
Job Description

Responsibilities:

 

  • Preparation, compilation and submission of dossier to Department of Health
  • Key liaison person for the Department of Health, oversea distributors and suppliers
  • Revision of product labelling, product inserts and promotional & marketing materials
  • Provision of updated regulatory guidance to marketing, product development and logistic teams
  • Assist in plant audit preparation, translation of clinical papers, SOPs and dossiers, website contents
  • Assist in ISOs, GMP, Kosher, Halal and other international quality audits and monitoring
  • Assist in Good Distribution Practice and warehouse monitory
  • Assist in patent, trademark application
  • Assist in clinical studies monitoring
  • Ad-hoc duties maybe be assigned
  • Less experienced candidate will be offered Regulatory Affairs Associate

 

Special requirements:

  • Degree in Science Related discipline, major in Pharmacy, or Pharmaceutical Science is preferable
  • At least 2 years regulatory experience of pharmaceutical and/or nutritional supplements is definite advantage
  • Ability to work under pressure
  • Independent, good time management and good team player
  • Proficiency in spoken and written English and Chinese
  • Immediate availability is highly preferred

 

Benefits

  • Five-day work
  • Bank Holidays
  • Performance bonus
  • Medical Insurance
  • 10+ Days Annual leave
  • Birthday leave
  • Paid Marriage Leave

 

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