Our company specializes in pharmaceutical products and dietary supplements in international market. To cope with our global expansion, we are seeking qualified candidates to join us.

Our company specializes in pharmaceutical products and dietary supplements in international market. To cope with our global expansion, we are seeking qualified candidates to join us.

Senior Regulatory Affairs Executive

Job level Middle
Work exp Minimum 3 Years
Education Bachelor Degree
Location
Tsimshatsui
Employment type Full Time
Industry Others
Job function Manufacturing > Product Development / Product Management
Marketing / Public Relations > Others
Medical Services > Pharmaceutical
Published On 18/05/2018

Responsibilities:

Regulatory affairs activities of pharmaceutical products, dietary supplements, functional foods and drinks as well as functional ingredients in Hong Kong and worldwide countries including:

  • 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
  • Involves in plant audit preparation, translation of clinical papers, SOPs and dossiers, website contents
  • Handling ISOs, GMP, Kosher, Halal and other international quality audits and monitoring
  • Involve in Good Distribution Practice and warehouse monitory
  • Handling trademark application
  • Monitoring clinical studies monitoring
  • Ad-hoc duties maybe be assigned

Special requirements:

  • Degree in Science Related discipline, major in Pharmacy, or Pharmaceutical Science is preferable
  • At least 3 years regulatory experience of pharmaceutical and/or nutritional supplements is definite advantage

Personal attributes:

  • Meticulous, flexibility, ability to work under pressure
  • Independent, good time management and good team player
  • Proficiency in spoken and written English and Chinese
  • Computer proficiency (Excel, Word, PowerPoint)
  • Immediate availability is highly preferred

Benefits:

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

Interested parties, please send email by clicking

Personal data will be used for recruitment purpose only.