Compliance

• Establish regulatory strategy and operations within the China biotech ecosystem
• Responsible for all regulatory activities (strategy and implementation) for ExploR&D’s China portfolio of projects
• Provide holistic guidance for overall drug development, to maximize the potential for each molecule
• Identify key development risks, accompanied by options, strategies for how to overcome or mitigate each risk, and contingency plans
• Lead, network, identify, and manage all regulatory outsourcing/third party vendor relationships and deliver project milestones on time, on budget, and within scope
• Interpret and educate peers on NMPA and other applicable Chinese regulations (e.g. HGRAC), ICH and global regulations, requirements, and guidance as it evolves to ensure sustained compliance and durability in the face of continuous pipeline innovation
• Engage with external partners and organizations to monitor, benchmark, and gather intelligence to influence Regulatory innovation internally
• Develop regulatory education programs to cultivate expertise as new therapeutic modalities emerge and clinical development operating models evolve
• Effectively partner across functions to identify and mitigate performance gaps relative to Regulatory requirements
• Ensure the ExploR&D Regulatory System in China provides fit for purpose methods and systems to assure trial participant safety, data integrity, and regulatory compliance

Senior Executive Director, ExploR&D, Global Regulatory Affairs

Statutory Compliance Supervisor