company

Regulatory Affairs Executive

Job Responsibilities

  • To assist in handling all regulatory affairs of Food & Health supplements, Chinese Medicine products, Western Medicine products & Cosmetics for Hong Kong and other overseas markets.
  • To participate in preparation, compilation and submission of dossier of both proprietary Chinese medicine AND pharmaceutical products to Department of Health for product registration.
  • To assist in monitoring and communicating within the company for the current and proposed changes on drug registration dossiers to ensure all the operations within company relating to product registration strictly comply with statutory regulatory requirements and business needs.
  • To coordinate and communicate with external testing organization on various contract-out testings for product registration.
  • To review and approve product labels, product inserts and promotional & marketing materials.
  • To provide updated regulatory guidance to internal stakeholders.
  • To carry out ad-hoc assignments as required.

Job Requirements

  • Bachelor’s degree or above in science, pharmacy, pharmacology or related disciplines.
  • Possess 2+ years in Regulatory Affairs role.
  • Knowledge in regulatory affairs and product registration for Hong Kong and overseas markets is highly preferred.
  • Good command of English and Chinese.
  • Diligent, well-organized and responsive.
  • Proactive, organized, highly adaptable and result-oriented.
  • Excellent presentation and communication skills.
  • Proficient in English and Chinese.