ra/qa/pv manager (pharmaceutical).

Our client is a reputable APAC pharmaceutical manufacturer, and they’re currently looking for a Manager, Regulatory Affairs, Quality Assurance & Pharmacovigilance to join their team.

about the job.

• Develop and implement regulatory strategies to ensure compliance with local and international regulations
• Manage regulatory submissions and communicate with health authorities to ensure timely approvals
• Develop and maintain the quality management system (QMS) to ensure product quality and compliance with GMP, GDP, and other relevant standards
• Implement and maintain the pharmacovigilance system to ensure compliance with local and international regulations
• Conduct product quality risk assessments and develop risk management plans
• Lead the preparation and submission of regulatory dossiers for new products, variations, and renewals
• Provide regulatory guidance and support to cross-functional teams
• Ensure compliance with adverse event reporting requirements and manage pharmacovigilance activities
• Manage quality-related investigations, deviations, and CAPAs to ensure timely resolution
• Prepare and conduct internal and external quality audits to ensure compliance with regulatory requirements
• Develop and deliver quality-related training to employees and contractors

skills & experiences required.

• Bachelor's degree in pharmacy or related field. Advanced degree is a plus
• Minimum 3 years of experience in regulatory affairs, quality assurance, and pharmacovigilance in the pharmaceutical industry
• Strong knowledge of local and international regulatory requirements and guidelines
• Experience in managing regulatory submissions and interactions with health authorities
• Familiarity with GMP, GDP, and other relevant quality standards
• Experience in managing pharmacovigilance activities and adverse event reporting
• Strong analytical, problem-solving, and project management skills
• Excellent communication, interpersonal, and leadership skills
• Fluent in English and Chinese (Cantonese and Mandarin)
• Ability to work independently and in a team environment

Interested individuals can click apply now and send through an updated resume in WORD format. For a more comprehensive list of current opportunities, please visit https://www.randstad.com/jobs/q-hong-kong/ or contact Jessica Cheung at + 852 6285 6991 or email jessica.cheung@randstad.com.hk

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