Regulatory Affairs Associate

1 week ago

hong kong, Hong Kong SAR China Chemill Pharma Ltd. Full time

The Regulatory Affairs Associate will provide comprehensive administrative and technical support to the Regulatory Affairs (RA) team, ensuring timely preparation, submission, and maintenance of product registrations and post‑approval activities in Hong Kong. The role supports regulatory documentation, coordination with manufacturers, and compliance with local regulatory requirements. Key Responsibilities Support the preparation, compilation, and submission of product registration dossiers to the Hong Kong Department of Health. Coordinate with internal teams and external partners to collect technical and administrative documents required for submission. Assist in reviewing and organizing quality, clinical, and administrative documents for compliance and accuracy. Maintain regulatory databases, submission trackers, and archives to ensure all records are accurate and up‑to‑date. Prepare standard templates, forms, and documents for local submissions. Ensure all correspondence, approvals, and regulatory commitments are properly filed and retrievable. Support variations, renewals, labeling updates, and other post‑approval changes. Monitor submission timelines and follow up with regulatory authorities and partners as required. Track and assist in responding to deficiency letters or information requests from the Department of Health. Liaise with global manufacturers, distributors, and local agents to ensure timely provision of data and documents. Collaborate closely with QA, Supply Chain, and Marketing teams to ensure product compliance and smooth market operations. Assist in monitoring local regulatory developments and updates from the Department of Health. Support the RA team in implementing changes to ensure ongoing compliance with updated guidelines and policies. Qualifications & Experience Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or related discipline. 1–3 years of experience in Regulatory Affairs within the pharmaceutical or healthcare industry. Strong understanding of the Hong Kong regulatory framework and documentation requirements. Experience with biosimilar submissions will be considered an added advantage . Excellent organizational, communication, and coordination skills. Attention to detail with the ability to manage multiple priorities in a deadline‑driven environment. Proficiency in English; Cantonese proficiency preferred, Mandarin is an advantage. Key Competencies Strong documentation and administrative skills. Proactive, detail‑oriented, and reliable team player. Good problem‑solving and time‑management abilities. Ability to communicate effectively with internal and external stakeholders. #J-18808-Ljbffr

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