[URGENT] Regulatory Affairs Specialist (25-30k)

Hong Kong

  • At least 2 yr of exp. in this field
  • Stable career, 5 day work
  • 14 AL, Medical, 1 month Gratuity

Duties:

  • End-to-end registration activities (pre- and post-approval, withdrawal) for Hong Kong and Macau markets for PharmaMedical Device.
  • Ensure new product submissions are filed with necessary documentation in timely manner
  • Liaise with Health Authority to ensure the product registrations can be approved within reasonable timeframe to support business plan
  • Ensure the internal systems, records and relevant processes are observed and up-to-date
  • Utilize different IT system to support daily RA operation such as new labeling development and manage RA projects.
  • Participating in cross-functional projects and input regulatory assessment.
  • Develop new label as per regulatory requirement and deploy the implementation plan with commercial and other functions.
  • Maintain the company record and SOP to maintain the wholesale dealer license
  • Keep abreast of regulatory environment and update relevant stakeholders to minimize the potential risk
  • Promotional Material review to ensure regulatory compliance
  • Provide regulatory support to business activities e.g. Hospital tenders and quotations
  • Apply different license as per business needs e.g. ISMEM
  • Participate in APAC regional projects to improve RA team operation efficiency and effectiveness
  • Close co-operation with QA on ad hoc issue e.g. product release, or field corrective action
  • Provide support for other ad hocrequests, e.g. regulatory information relevant to mitigating supply issue, or named-patient supply

Requirements:

  • University graduate in biological science
  • Minimum 2-3 years’ experience in regulatory affairs (or Quality Assurance) in pharmaceutical or medical device company
  • Fluent in English and Cantonese

Interested parties please email a MS Word version resume and expected salary to pinky.wu@manpowergrc.hk (cc:  it@manpower.com.hk) and quote the job reference no.





Type: Contract

Category: Healthcare & Medical - No Selection Required

Reference ID: 506-260610-PW

Date Posted: 10/06/2026

Shortcut: http://jobs.manpowergrc.hk/KrWiAL

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