4 days ago Be among the first 25 applicants Direct message the job poster from SINOVAC BIOTECH LTD. The RA manager role will support the implementation of Hongkong's regulatory strategies and affairs for all products, assuring it is aligned with Hongkong’ requirements from a local perspective. Job Responsibilities Communicate with PPB (Pharmacy and Poisons Board) to discuss regulatory issues and formulate local registration strategy. Screen deficiencies, review and submit relevant dossier to PPB and follow up registration progress and status timely. License maintenance and post approval supplement, such as change control, pharmacovigilance support. Collecting relevant regulations and products information of other companies. Technical support to the sales department when requested Preferred Qualifications Experienced on regulatory affairs，general experience on quality, GMP and clinical studies. Knowledge regulations of Hongkong is essential. Language skills in excellent English and Mandarin is essential. Preferred at least 5 years of work experience on pharmaceutical products, especially on vaccines or biological products. Previous experience as a national and/or regional regulatory liaison for a product in different stages of its life cycle is highly desirable. The position will require rich experience in regulatory affairs, strong communication skills and public relation skills, strong Hongkong’s background. Why Join Us?Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases. Our mission is to supply vaccines to eliminate human diseases. We are actively seeking a Regulatory Affairs Consultant who is experienced in regulatory affairs to facilitate regulatory work in Saudi Arabia and GCC region. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Health Care Provider, Product Management, and Science Referrals increase your chances of interviewing at SINOVAC BIOTECH LTD. by 2x Sign in to set job alerts for “Regulatory Affairs Manager” roles. Assistant Manager/ Manager – Regulatory & Compliance Manager, Regulatory Compliance (SFC/Insurance Focus)Assistant Manager/Manager, Regulatory & Management Reporting Specialist, Network Planning and Regulatory Affairs We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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