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Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
People Leader
All Job Posting Locations:
Beijing, China
Job Description:
Key Responsibility
Define & shape China regulatory strategy and orchestrate the execution across the Immunology Therapeutic Area (IMM TA) portfolio for R&D development, business success and priorities and lifecycle management, to unlock patient access and commercial value.
- Own the end-to-end China regulatory strategy for the entire Immunology portfolio and drive all regulatory activities. Set the overarching regulatory roadmap aligned with global R&D and commercial business priorities, with full accountability for shaping the regulatory direction of multiple assets across the immunology portfolio.
- Build robust China Immunology TA regulatory capabilities and regulatory insights. Proactively monitor changes to the regulatory environment and industry landscape, identify strategic opportunities, guide the team to deliver technical input, translate expert recommendations into actionable regulatory strategies, and drive the implementation.
- Lead the team to strategically define comprehensive regulatory pathways and continuously pursue innovative regulatory approaches (e.g., priority review, Breakthrough Therapy, rare disease / orphan designation, pilot program, etc).
- Facilitate HA meetings (e.g., NMPA pre-IND and pre-NDA consultation meetings) supported by team members with well-prepared pre-meeting strategy and targeted communication plans. On one hand, coordinate internal communication and resources to achieve defined meeting objectives, secure favorable regulatory feedback for asset development. On the other hand, execute post-meeting action plans, maintain ongoing follow-up with health authorities, and deliver on meeting outcomes.
- Guide team to evaluate target submission and approval timelines, POS, and change management based on R&D and business strategy requirements and ensure timely alignment with key stakeholders. Lead submission timelines and cadence planning, identify critical-path items and bottlenecks, mobilize internal and external resources to deliver IND/NDA/Variation and other submission milestones, and provide timely updates to stakeholders.
- Drive the development of a comprehensive labeling strategy with team members. Strategically design label claims and supporting evidence packages aligned with clinical data, scientific rationale and company positioning. Lead cross-functionally aligned HA negotiations to secure a label that maximizes patient access and product therapeutic value.
- Lead the team to anticipate HAQs proactively, build evidence matrix and define optimized response strategy. Lead cross-functional teams to deliver robust, consistent responses to verbal and written HA queries to protect regulatory submissions.
- Partner with CMCRA and CMC teams (e.g., DPDS, Supply Chain, Quality) to co-develop the China CMC regulatory strategy in Immunology RA, identify CMC-related risks and define mitigation plans. Integrate the CMC strategy into the overall regulatory strategy to secure regulatory approvals for Immunology TA.
Regulatory Leadership: Strategic Regulatory Inputs & Cross-Functional partnership
- Build and lead the RA team to serve as the regulatory representative in Global Regulatory Team (GRT) meeting, Project Team (PT) meeting and other project forums, providing regulatory perspectives to align cross-functional objectives and unblock issues. Ensure close alignment with Global Regulatory Affairs (GRA) on regulatory strategy and with Project Teams to maximize development, patient benefit and commercial value.
- Partner with R&D, Commercial, Quality, Supply Chain and Pharmacovigilance to ensure consistent local, regional and global communication and execution. Act as a regulatory subject-matter expert embedded in cross-functional teams to provide regulatory input and enable collective decision-making.
- Maintain clear escalation processes to ensure significant regulatory information received from Health Authorities is communicated and actioned appropriately.
- Collaborate with cross-functional team to assess regulatory impacts of product launch and supply-chain changes and provide regulatory constraints and expert recommendations.
- Evaluate the impacts of regulatory changes and emerging practices on Immunology TA.
External Engagement & Industry Interaction
- Maintain professional engagement with CDE/NMPA and other Health Authorities and build robust partnerships to support Immunology portfolio development.
- Monitor domestic regulatory and guideline updates relevant to Immunology and provide feedback on draft regulations, and gather industry intelligence.
- Support GMP and GCP inspection readiness activities for Immunology projects.
- Establish and nurture connections with Immunology external experts (KOLs) to track evolving regulatory practices and continuously elevate the company’s regulatory capabilities.
Team leadership & resourcing
- Build a robust registration team and drive talent development
- Team attendance management, performance management and annual budget planning.
- Support headcount and budget planning accuracy of RA department
- Oversee outsourced vendors; manage outsourcing project delivery and quality.
M&A, BD and Incident Response
- Support regulatory due diligence for mergers, acquisitions, licensing and BD transactions; identify transaction-related regulatory risks.
- Lead cross-functional emergency response and remediation for regulatory inspections, significant safety or compliance events.
Core competencies
- Strategic thinking: Strategic thinker with strong business acumen and an enterprise mindset. Can exercise excellent judgment in assessing priorities and initiating projects; employ novel approaches to regulatory issues in response to a changing regulatory landscape, interpret regulatory legislation and processes to propose innovative solutions for regulatory and policy challenges. Able to combine strategic vision with execution excellence to drive change and deliver impact.
- Business acumen: Possess sharp business sense, capable of making complex decisions to resolve regulatory or business issues, with acute understanding of the impact of decisions taken. Proactively identify issues, assess risks and success probability, and provide actionable solutions and recommendations.
- Learning skill: High learning agility, adaptable and open-minded, willing to work under high pressure and thrive in ambiguous, uncertain environments. Can make informed decisions under uncertainty, take ownership and drive results.
- Communication skill: Excellent communication, presentation and stakeholder management skills; fluent in written and spoken English. Build effective, trustful relationships with multi-functional stakeholders within complex organizations; skilled at negotiation and computer literacy.
- Influence capability: Proven ability to collaborate, influence and lead cross-functional teams in matrix organizations; strong lobbying & negotiation capability. Able to work across global businesses & cultures to align regional and global strategy and compliance, convey proposals and influence key internal decision-makers.
- Excellent working knowledge of the China regulatory framework and how that applies to pharmaceutical and healthcare product development.
- Accountable, self-motivated, with a strong can-do attitude.
- Strong analytical and problem-solving skills, capable of synthesizing complex information and making sound judgments.
- Demonstrates cultural agility to navigate complex global organizational environments effectively.
Education and Experience requirement
- A scientific background with an advanced degree in chemistry, pharmaceutics, biology or a related lifescience discipline.
- >12 years of regulatory affair experience including 5 years in managerial role in a multinational pharmaceutical company.
- Biological experience is preferred.
- Direct or matrixed people management experience preferred.
Other Comments:
- Proficient use of technology, including Microsoft Office programs and Internet resources.Some domestic and international travel business travel (10-15%) is required,
- Ability to work flexible hours to accommodate early morning/evening meetings and teleconferences across different time zones.
Required Skills:
Preferred Skills:
Business Writing, Collaboration, Compliance Risk, Continuous Improvement, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking