(Pharma) Senior Manager RA & QA

KOS International Limited; Hong Kong; On-site; HKD 900,000 - 1,300,000; Full time

Job summary

KOS International Limited in Hong Kong seeks a Senior Manager, Quality Assurance & Regulatory Affairs to lead the QA/RA function, ensuring compliance with local and international regulations across pharmaceuticals, healthcare products, and devices.

The role oversees regulatory submissions, pharmacovigilance, and quality systems, partnering with commercial and operations teams to drive risk management and continuous improvement. Strong leadership and HK regulatory knowledge are essential.

Qualifications

• Bachelor's Degree in Pharmacy or related life science.
• 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.

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.

Skills

Regulatory Affairs

Quality Assurance

People Leadership

Stakeholder Management

Quality Systems

Education

Bachelor's Degree in Pharmacy or Life Sciences

Job description

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.