Regulatory Affairs Specialist

Key Responsibilities:

• Dossier Management:

  • Lead the preparation, compilation, and submission of dossiers to the Hong Kong Department of Health.
  • Conduct in-depth reviews of technical, clinical, and quality documentation provided by manufacturers.
  • Ensure all dossiers meet current regulatory guidelines, standards, and local requirements.

• Manufacturer Liaison:

  • Collaborate with manufacturing partners to gather accurate and complete regulatory documentation.
  • Review and align product information, Certificates of Analysis (COAs), stability data, and analytical comparability reports.

• Regulatory Compliance:

  • Interpret and implement the latest local regulations and guidance documents.
  • Monitor regulatory changes and provide internal updates to ensure continued compliance.

• Authority Interaction:

  • Manage direct communication with the Department of Health and respond to deficiency letters or inquiries in a timely manner.
  • Attend briefings, stakeholder consultations, and training sessions hosted by regulatory authorities.

• Labelling & Documentation:

  • Ensure local labeling compliance including accurate bilingual (English + Traditional Chinese) translations and format alignment with Hong Kong’s regulatory standards.
  • Maintain up-to-date knowledge of biosimilar naming conventions, interchangeability, and pharmacovigilance requirements.

• Regulatory Strategy & Lifecycle Support:

  • Support regulatory strategy development for new biosimilar product launches and variations (e.g., renewals, line extensions, post-approval changes).
  • Contribute to the creation of submission plans, timelines, and risk assessments.

• Documentation & Recordkeeping:

  • Maintain meticulous records of submissions, approvals, correspondences, and post-approval commitments.
  • Draft and manage Hong Kong-specific SOPs related to biosimilar regulatory filings and submissions.

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Qualifications & Skills:

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
• Atleast 2 years of hands-on regulatory affairs experience in the pharmaceutical or biopharmaceutical industry, with a strong focus on biosimilars and/or biologics.
• Sound understanding of Hong Kong’s regulatory environment for biosimilars is an added advantage.
• Experience in preparing and submitting dossiers.
• Strong coordination skills with external partners, contract manufacturers, and CROs.
• Excellent written and verbal communication skills in English. Proficiency in Cantonese is essential; Mandarin is a plus.
• High attention to detail, problem-solving mindset, and strong organizational skills.
• Ability to manage multiple projects and work in a dynamic, deadline-driven environment.