Regulatory Affairs Manager

General Responsibilities:

• Leading the development and execution of integrated medical strategies and annual medical plans based on scientific insights, patient needs, clinical practice gaps, and business priorities
• Launch excellence experience
• Driving evidence generation initiatives by providing strategic oversight of study concepts, protocol development, study execution, publication planning, and dissemination of scientific outcomes
• Providing senior medical leadership in product launches, lifecycle management, and cross-functional strategic discussions, ensuring scientific credibility and compliance
• Leading high-quality scientific engagement activities, including advisory boards, expert meetings, congress activities, and medical education programs that address evolving healthcare needs
• Monitoring emerging scientific evidence, clinical guidelines, competitive intelligence, and healthcare trends to generate actionable insights that inform medical and business decisions
• Building and strengthening partnerships with key opinion leaders, medical societies, healthcare institutions, and internal stakeholders across local, regional, and global teams
• Providing expert medical review and governance for promotional, educational, scientific, and project-related materials to ensure compliance, accuracy, and appropriate risk management
• Coaching and mentoring medical colleagues and cross-functional partners while promoting capability building, scientific excellence, and a culture of continuous learning

Job Requirements:

• Advanced degree in Medicine, Pharmacy, Life Sciences, Biomedical Sciences, or a related discipline; MD, PharmD, PhD, or equivalent qualification is highly preferred
• Minimum 5 years of relevant experience in Medical Affairs, clinical development, pharmaceutical industry, academic research, or related healthcare functions in the Hong Kong healthcare and pharmaceutical landscape.
• Demonstrated experience leading medical strategy development, evidence generation, scientific engagement, and medical governance activities
• Strong understanding of GCP, healthcare compliance, regulatory requirements, medical governance frameworks, and industry standards
• Proven ability to influence cross-functional and senior stakeholders through credible scientific leadership and strategic thinking
• Experience designing, overseeing, or supporting evidence generation programs, including clinical studies, investigator-sponsored research, and publication activities
• Exceptional communication, scientific presentation, and stakeholder engagement skills with the ability to translate complex scientific data into meaningful medical insights

General Responsibilities:

• Leading the development and execution of integrated medical strategies and annual medical plans based on scientific insights, patient needs, clinical practice gaps, and business priorities
• Launch excellence experience
• Driving evidence generation initiatives by providing strategic oversight of study concepts, protocol development, study execution, publication planning, and dissemination of scientific outcomes
• Providing senior medical leadership in product launches, lifecycle management, and cross-functional strategic discussions, ensuring scientific credibility and compliance
• Leading high-quality scientific engagement activities, including advisory boards, expert meetings, congress activities, and medical education programs that address evolving healthcare needs
• Monitoring emerging scientific evidence, clinical guidelines, competitive intelligence, and healthcare trends to generate actionable insights that inform medical and business decisions
• Building and strengthening partnerships with key opinion leaders, medical societies, healthcare institutions, and internal stakeholders across local, regional, and global teams
• Providing expert medical review and governance for promotional, educational, scientific, and project-related materials to ensure compliance, accuracy, and appropriate risk management
• Coaching and mentoring medical colleagues and cross-functional partners while promoting capability building, scientific excellence, and a culture of continuous learning