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Associate Director/Director-Regulatory Affairs (Intelligence & Policy), China

Purpose:

The purpose of the Associate Director/Director (Regulatory Affairs Intelligence & Policy) role is to monitor the China regulatory environment and ensure timely provision and dissemination of regulatory intelligence to China Regulatory Affairs (RA), other relevant China functions, and global stakeholders. This role leverages local and global expertise to influence the regulatory ecosystem, enabling efficient and effective decision-making and supporting predictions to capitalize on regulatory opportunities while mitigating risks.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Regulatory intelligence Excellence

Ensure timely dissemination of intelligence to relevant contacts.Identify and access relevant Information sources, establish sustainable databases to search for regulatory information and summarize regulatory intelligence.Summarize, Analyze, Integrate, Interpret, Present information and intelligence working with customers (China RA team/China medical organization/China affiliate/AP region and global).Support the regulatory scientist in developing and refining the regulatory strategy, including using the information to confirm/challenge/influence the regulatory strategies based on industry precedent and new developments, etc.Provide answers to strategic regulatory questions to influence and drive decisions and predict the regulatory landscape.Partner with the internal GA/CA group in the coordination of and contribution to company positions on issues impacting regulatory affairs by liaising with relevant components, as needed.Provide consultation on regulatory issues and regulatory risks proactively to various functions in a timely manner.

Interpret and assess impact of new regulatory guidelines

Monitor the regulatory landscape – legislations, regulations, guidance documents, regulatory agency opinions, etc.Understand and interpret impact to regulatory strategy.Collaborate with their global or regional counterpart to stay informed of the global environment.

Establish Regulatory Policy Positions and External Engagement Strategies

Align on Lilly’s global and China-specific priority regulatory topics, consistent with Lilly overall regulatory policy vision.Identify and articulate regulatory policy challenges, problem statements, and desired future states relevant to the China regulatory environment.Generate and/or leverage internal and/or external evidence (including China-specific data and case studies) to effectively support Lilly’s positions.Cultivate relationships and collaborate with internal subject matter experts and China RA teams to create evidence and policy positions.Develop policy narratives and messages tailored for China, and gain agreement from local and global stakeholders.Execute external engagement strategies, including active participation in China-based industry associations and regulatory forums, to deliver Lilly’s messages.Integrate external viewpoints from Chinese regulatory authorities, industry peers, and other stakeholders as company positions are developed.Encourage internal stakeholders to consider innovative approaches to regulatory policy issues and advocate for mutually beneficial (win-win) solutions.Prepare senior leaders for China regulatory policy engagement through formal and informal briefings as requested.

Exert External Influence

Build and maintain relationships with key external stakeholders in China, including regulatory authorities (e.g., NMPA), industry associations, academic institutions, and industry peers, to understand their perspectives and share Lilly’s positions.Identify and leverage strategic relationships to advance Lilly’s regulatory policy priorities in China.Promote Lilly’s positions through targeted communication plans and active participation in China-based trade association teams.Lead or support regulatory policy initiatives across the China pharmaceutical industry, in alignment with Lilly’s global and local priorities.

Operational/People Excellence

Assembles external resources to resolve regulatory issues as appropriate.Identify for opportunities to improve processes and products based on the information.

Minimum Qualification Requirements:  

At least bachelor degree in pharmaceutical or chemical/biopharmaceutical sciences, regulatory experience is preferred.Excellent command of English in writing, presentation, and listening.Proven ability to positively influence colleagues and teams through collaboration and leadership, and be willing to coach and develop people.Skilled in computer systems and application software, including search engines and database navigation.Demonstrated analytical and problem-solving skills.Ability to interpret complex regulatory information and assess strategic impact.Self-motivated, innovative, and adaptable in a dynamic environment.Strong interpersonal skills with a focus on teamwork and knowledge sharing.

Other Information/Additional Preferences:

N/A

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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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