锦鲤求职岗位描述
Senior Manager, Quality Assurance & Regulatory Affairs (Confidential Search)
About the Opportunity
An established healthcare and pharmaceutical organization is seeking an experienced Quality Assurance & Regulatory Affairs leader to drive regulatory compliance, quality excellence, and business growth across Hong Kong.
This is a strategic leadership position offering exposure to pharmaceuticals, medical devices, quality systems, regulatory affairs, pharmacovigilance, and team management. The successful candidate will play a key role in shaping quality and regulatory strategy while partnering closely with commercial and operational stakeholders.
Key Responsibilities
Lead the Quality Assurance & Regulatory Affairs function, ensuring compliance with all applicable local and international regulations.
Manage product registrations, renewals, variations, and submissions for pharmaceutical and healthcare products.
Act as the primary liaison with regulatory authorities regarding product registration, licensing, and compliance matters.
Oversee quality management systems and ensure compliance with applicable quality standards and certifications.
Support secondary packaging operations and ensure adherence to relevant regulatory requirements.
Ensure regulatory documentation, licenses, and records are maintained accurately and efficiently.
Partner with cross-functional teams to drive quality initiatives, risk management, and continuous improvement programs.
Maintain effective pharmacovigilance processes and ensure compliance with local regulatory requirements.
Lead, mentor, and develop a high-performing QA/RA team.
Support business-critical projects and strategic initiatives as required.
Requirements
Bachelor's Degree in Pharmacy or a related life science discipline.
Solid experience in Regulatory Affairs and Quality Assurance within pharmaceutical, medical device, healthcare, or related industries.
Proven people management and leadership experience.
Strong knowledge of Hong Kong healthcare regulations and product registration processes.
Familiarity with quality management systems and compliance standards.
Strong communication and stakeholder management skills.
Fluent in English, Cantonese, and Mandarin.
Click "Apply Now" to apply for this position or call Anson Lin at +852 3180 4978 for a confidential discussion. All information collected will be kept in strict confidence and will be used for recruitment purpose only.