Regulatory Affairs
6 days ago
Regulatory Affairs & Quality Assurance Specialist The Regulatory Affairs & Quality Assurance Specialist will play a key role in managing all regulatory activities related to the registration, approval, and lifecycle maintenance of 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: Lead the preparation, compilation, and submission of 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. 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 interchangeability and pharmacovigilance requirements. Regulatory Strategy & Lifecycle Support: Support regulatory strategy development for new 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 regulatory filings and submissions. Qualifications & Skills: 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 requirement. 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. Experience in team management and leadership skills. Ability to manage multiple projects and work in a dynamic, deadline‑driven environment. Knowledge of biosimilar product registration is an added advantage. Application Questions: What's your expected monthly basic salary? How many years' experience do you have as a Regulatory Affairs Manager? How many years' experience do you have in a quality assurance (QA) role? #J-18808-Ljbffr
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Regulatory Affairs Pharmacist
2 weeks ago
Kowloon, Hong Kong SAR China Jacobson Group Management Limited Full timeHandle all regulatory related matters of assigned portfolio/markets, including but not limited to pharmaceutical products, medical devices, consumer goods and health foods, as well as related marketing activities in Hong Kong and Macau; Monitor regulatory updates and provide regulatory support to internal and external parties; Coordinate prompt registration...
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Regulatory affairs associate
2 weeks ago
Kowloon, Hong Kong SAR China Chemill Pharma Limited Full timeThe Regulatory Affairs Associate will provide comprehensive administrative and technical support to the Regulatory Affairs (RA) team in ensuring timely preparation, submission, and maintenance of product registrations and post-approval activities. This role is crucial in assisting with regulatory documentation, coordination with manufacturers, and ensuring...
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Regulatory Affairs Manager
15 hours ago
Kowloon, Hong Kong SAR China Camber Pharmaceuticals Inc Full timeAbout Camber Pharmaceuticals For over 15 years, Camber Pharmaceuticals has been one of the fastest-growing generics companies in the United States. Since its inception, Camber has shown a tradition of excellence and a deep commitment to providing cost-effective processes to treat a wide range of therapeutic categories. Through our parent company, Hetero (...
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Regulatory Affairs
6 days ago
Kowloon, Hong Kong SAR China Chemill Pharma Limited Full timeA leading pharmaceutical company in Hong Kong is seeking a Regulatory Affairs & Quality Assurance Specialist. You will manage regulatory activities related to product approval and compliance. Ideal candidates have 3–5 years of experience in regulatory affairs, strong knowledge of Hong Kong regulations, and excellent communication skills in English and...
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HK Regulatory Affairs Associate: Dossiers
2 weeks ago
Kowloon, Hong Kong SAR China Chemill Pharma Limited Full timeA pharmaceutical company in Hong Kong is seeking a Regulatory Affairs Associate to provide administrative and technical support. You will assist in the preparation and submission of product registrations, ensuring compliance with local regulations. Ideal candidates hold a degree in a relevant field and have 1-3 years of experience in Regulatory Affairs,...
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Assistant Regulatory Affairs
1 week ago
Kowloon, Hong Kong SAR China Chemill Pharma Limited Full timeA pharmaceutical company in Hong Kong is seeking an Assistant Regulatory Affairs & Quality Assurance Manager. The role involves managing all regulatory activities related to product registrations and approvals, ensuring compliance with local requirements. Key responsibilities include preparing registration dossiers, conducting detailed reviews of...
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Assistant Regulatory Affairs
1 week ago
Kowloon, Hong Kong SAR China Chemill Pharma Limited Full timeAssistant Regulatory Affairs & Quality Assurance Manager The Assistant Regulatory Affairs & Quality Assurance Manager will play a key role in managing all regulatory activities related to the registration, approval, and lifecycle maintenance of products in the Hong Kong market. This position requires close collaboration with global manufacturers, internal...
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Pharma Regulatory Affairs Exec — Flexible Hours
2 weeks ago
Kowloon, Hong Kong SAR China Trenton-Boma Limited Full timeA pharmaceutical distributor in Hong Kong is seeking a Pharmaceutical Regulatory Affairs Executive. The role involves collaborating with overseas suppliers to obtain necessary documentation, managing regulatory plans, and preparing submissions to Regulatory Authorities. Candidates should have a degree in a relevant field and possess excellent communication...
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Regulatory Affairs Pharmacist
2 weeks ago
Kowloon, Hong Kong SAR China Jacobson Group Management Limited Full timeA reputable management firm in Hong Kong is seeking a Regulatory Affairs Pharmacist to handle regulatory matters for pharmaceutical products and medical devices. The ideal candidate will possess a degree in Pharmacy and have strong communication skills in both English and Chinese. Responsibilities include managing product registrations, maintaining...
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Regulatory Affairs: HK Drug Registration
15 hours ago
Kowloon, Hong Kong SAR China Camber Pharmaceuticals Inc Full timeA leading pharmaceuticals company is seeking a Regulatory Affairs Specialist in Hong Kong. The candidate will manage drug registration dossiers and ensure compliance with regulatory requirements. Ideal applicants will have at least 1 year of experience in drug registration and HA tendering processes. Exceptional communication skills in English and Cantonese,...
