Senior /Executive Director ExploR&D Global Regulatory Affairs – China

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Senior/Executive Director
ExploR&D Global Regulatory Affairs – China

Path / Level: P5

Overview

Lilly Catalyze360 is Lilly's comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars—Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLabs—Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning.

Lilly ExploR&D is a team of drug discovery and development experts who partner with biotechs from discovery through clinical proof-of-concept, putting Lilly's industry-leading capabilities behind their missions. We provide flexible support—from strategic consulting to full program execution—making it faster, easier, and more capital-efficient for innovators to transform bold science into life-changing medicines.

The Senior/Executive Director ExploR&D Global Regulatory Affairs – China will establish regulatory strategy and operations within the China biotech ecosystem. This role will be responsible for establishing local infrastructure to meet the needs of local biotechs. This role will lead the organization through evolving local regulatory requirements by articulating a clear strategic vision that pushes the boundaries for how work is performed to enable ExploR&D to move faster, innovate rapidly, and be more efficient.

The Senior/Executive Director will provide deep regulatory expertise to the increasingly complex demands of working with novel modalities and external biotech partners and will be responsible for execution of innovative regulatory strategies. The successful candidate will partner with multiple functions, stakeholders, and third parties involved in the design and delivery of preclinical and early phase clinical development programs and use their regulatory expertise to influence strategic decisions and enable delivery of reliable results. The Senior/Executive Director will amplify their regulatory influence through coaching and mentoring and lead efforts to establish robust processes.

Key Responsibilities

• 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.
• Ability to navigate regulatory strategies across multiple therapeutic areas and modalities.
• 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.

Minimum Requirements

Education:

• Advanced graduate degree (MS, PharmD, PhD, MD) in a health-related or scientific field from an accredited college or university

Experience:

• Minimum 7 years’ experience in regulatory affairs focused on research-based drug development in China, including early phase (first in human, Phase 1/Phase 2) IND/CTA submission experience and experience leading NMPA meetings and negotiations.

Required Skills:

• Fluent Mandarin speaker; Advanced to Proficient in English (written and verbal)
• Innovation mindset
• Ability to leverage technology and new approaches to increase efficiency
• Strong leadership abilities, strategic thinking, and entrepreneurial mindset
• Judgment-based decision-making skills
• Ability to operate across boundaries (cross-functional and cross-company)
• Excellent communication and interpersonal skills
• Ability to manage risk
• Motivated, committed, and self-managed
• Strategic thinker, open-minded, and innovative

Additional Skills/Preferences

• Experience with conduct of investigator-initiated trials in China
• Understanding of global regulatory frameworks (FDA, EMA, etc.) and how they interface with Chinese requirements
• Strong analytical and problem-solving skills
• Experience with AI/ML tool development

Additional Information

Location: Shanghai, China  

Reporting: This role will report locally to the Vice President,  Head of China ExploR&D with a dotted line to the Associate Vice President, ExploR&D, Global Regulatory Affairs and Quality Assurance (located in Indianapolis, IN, USA). 

Travel up to 30%

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Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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