Regulatory Affairs / Quality Assurance Pharmacist
# Regulatory Affairs / Quality Assurance Pharmacist **APT Pharma Ltd** · Hong Kong · `On-site` 🕒 **Статус:** *Опубликовано: вчера* · *Источник: Indeed* --- ### About the Role APT Pharma Limited is an Equal Opportunities Employer. Personal data provided by job applicants will be used strictly in accordance with our personal data policy and for recruitment purposes only. We aim to respond to successful applicants within 8 weeks and related information will be kept in our file for up to 12 months for other suitable vacancies in our organization and thereafter destroyed. Key Roles and Responsibilities Responsible for regulatory affairs activities of assigned portfolio/ markets, including but not limited to new drug product registrations, Change of Registered Particulars (CORP) Applications and license maintenance; Ensure high quality submission files are prepared in compliance with regulatory requirements; Deliver regulatory affairs milestones in a timely manner and keep relevant parties updated with progress; Ensure transparent and efficient communication on issues that may affect regulatory affairs progress; Provide regulatory support on products supplied to HK government sectors, e.g. tender applications, change in registered particulars, etc. Assist in qualification and validation activities in accordance with GMP requirements. Support in developing, implementing and maintaining the documentation and quality assurance system of the company; Ensure the adequate records are maintained for controlling and monitoring conformity to specified GMP and statutory requirements; Support the routine QA Department functions, including self-inspection, regulatory affairs, products complaints/returns/recalls, etc.; Assist ad-hoc projects and administrative tasks assigned by the Manager; Knowledge in Quality Management System (e.g. change control, risk assessment and CAPA) is an advantage. Qualification and Experience Bachelor Degree or above in Pharmacy, Pharmaceutical or science-related disciplines; Work independently with good analytical skills and attention to detail; Strong communication skill, good command of English and Chinese; Self-motivated, responsible, reliable with attention to detail; Previous experience in new drug products registrations in Hong Kong will be beneficial for this role; Fresh graduates will also be considered. How to Apply You are invited to send in your application and CV stating the position (with reference number) you are applying for together with your current and expected salary, apply via CTgoodjobs on or before 30 October 2026. APT Pharma Limited is an Equal Opportunities Employer. Personal data provided by job applicants will be used strictly in accordance with our personal data policy and for recruitment purposes only. We aim to respond to successful applicants within 8 weeks and related information will be kept in our file for up to 12 months for other suitable vacancies in our organization and thereafter destroyed. Full-time
Наблюдалась 2026-09-22, впервые 2026-09-21, источник — Indeed.