Regulatory affairs associate
3 days ago
The 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 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 and Cantonese, Mandarin is an advantage. 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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HK Regulatory Affairs Associate: Dossiers
3 days 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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Regulatory Affairs Pharmacist
3 days 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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Manager, Regulatory Affairs, APAC
7 days ago
Kowloon, Hong Kong SAR China Johnson & Johnson Innovative Medicine Full timeManager, Regulatory Affairs, APAC Johnson & Johnson Innovative Medicine is seeking a Manager, Regulatory Affairs to join the Regulatory Affairs APAC team. The role is part of the Global Regulatory Affairs organization, based in the AP Region, and works with local regulatory affairs departments, AP regional cross‑functional teams, Global Regulatory Teams,...
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Director, Group Regulatory Affairs
7 days ago
Kowloon, Hong Kong SAR China Standard Chartered Full time3 days ago Be among the first 25 applicants Job Summary The role of Group Public & Regulatory Affairs (GPRA) is to collaborate with internal and external stakeholders, driving the alignment of the Bank’s strategy and global public policy, regulatory and supervisory objectives. The remit of the group covers policy, regulatory and supervisory issues...
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APAC Regulatory Affairs Manager: Strategy
7 days ago
Kowloon, Hong Kong SAR China Johnson & Johnson Innovative Medicine Full timeA leading pharmaceutical company is seeking a Manager, Regulatory Affairs to navigate and optimize regulatory strategies in the APAC region. You will collaborate with global and regional teams, providing regulatory support, leading submissions, and ensuring compliance with local laws. The ideal candidate will have significant experience in the pharmaceutical...
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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
3 days 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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Kowloon, Hong Kong SAR China Tevapharm Full timeA leading pharmaceutical company in Hong Kong is searching for a Regulatory Affairs professional to manage product compliance and submissions. This full-time role requires a degree in Life Sciences and at least two years of industry experience. Responsibilities include coordinating regulatory activities, ensuring compliance with local guidelines, and...
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Pharmaceutical Regulatory Affairs Executive
5 days ago
Kowloon, Hong Kong SAR China Trenton-Boma Limited Full timePharmaceutical Regulatory Affairs Executive A pharmaceutical distributor established in 2000, specializing in the marketing of top-quality generic pharmaceuticals and biopharmaceuticals imported from Europe, Canada, and Asia. Our extensive product range includes over 300 items, and we have a broad distribution network that covers private doctors, private...
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Senior Specialist, Regulatory Affairs
3 days ago
Kowloon, Hong Kong SAR China Tevapharm Full timeSelect how often (in days) to receive an alert: Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the...
