Assistant Regulatory Manager - Biosimilars

Chemill Pharma Ltd.

  • Hong Kong
  • Permanent
  • Full-time
  • 4 days ago
The Assistant Regulatory Affairs Manager – Biosimilars will play a key role in managing all regulatory activities related to the registration, approval, and lifecycle maintenance of biosimilar products in the Hong Kong market. This position requires close collaboration with global manufacturers, internal cross-functional teams, and regulatory authorities to ensure compliance with evolving regulatory requirements and timely product approvals.Key Responsibilities:
  • Dossier Management:
  • Lead the preparation, compilation, and submission of biosimilar registration 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 for biosimilars.
  • 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.
Qualifications & Skills:
  • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
  • 3–5 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.
  • 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.
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