Regulatory Affairs Head, TA

Role Purpose 职位目标 The Regulatory Affairs (RA) Therapeutic Area (TA) Head is a senior leadership role within GSK China’s Regulatory Affairs organization. As a key strategic leader, the individual will drive the regulatory strategy for critical Therapeutic Areas, enabling GSK’s growth, innovation, and long-term success in one of the most complex and rapidly evolving healthcare markets globally. In this role, the RA TA Head will act as a trusted advisor to senior leadership, providing expert guidance on regulatory strategies that ensure the timely registration and launch of innovative medicines. The role demands a deep understanding of the regulatory landscape, strong relationships with health authorities, and the ability to lead a high-performing team to deliver exceptional results aligned with GSK’s vision and priorities. Lead and direct regulatory staffs to develop optimal regulatory strategies and provide technical regulatory support for the purpose of maximizing GSK China Rx business by timely submissions and registration approvals. Constantly monitor the regulatory environment to ensure the company’s products are regulatory compliance. Develop overall capability and build a competent Rx products regulatory affairs team. Provide long-term regulatory strategy for portfolio management and exert external influence to shape the environment for expediting new product access in China. Senior Leadership Excellence As a senior leader within GSK China, the RA TA Head will play a pivotal role in shaping regulatory strategies and driving organizational success within a highly dynamic and competitive market. This involves spearheading critical decisions related to regulatory submissions, portfolio management, and cross-functional collaboration. The role demands visionary leadership to navigate the evolving regulatory landscape, ensure alignment with global and local objectives, and drive GSK’s strategic ambitions in China. Compliance and Risk Management This role carries high accountability for ensuring the TA portfolio adheres to strict regulatory compliance and aligns with both local and global requirements. The RA TA Head will proactively identify, assess, and mitigate regulatory risks, ensuring uninterrupted patient access to GSK’s medicines and safeguarding the company’s reputation. This includes building trusted relationships with health authorities and maintaining GSK’s commitment to ethical and compliant operations. Innovation and Performance Impact The RA TA Head will be responsible for delivering operational and regulatory excellence that is critical to achieving GSK’s growth, innovation, and business objectives in China. By driving timely, high-quality submissions and approvals, this role ensures that GSK’s portfolio continues to address unmet medical needs and supports the company’s position as a leader in pharmaceutical innovation. The ability to deliver results against ambitious corporate KPIs and timelines will be essential to success. Organizational Influence and Development As a senior role model, the RA TA Head will embody and promote GSK’s culture. This includes fostering a high-performance culture, inspiring trust and confidence, and ensuring the professional growth and development of the Regulatory Affairs team. The RA TA Head will play an integral role in driving organizational transformation and positioning GSK as a trusted and forward-thinking pharmaceutical leader in China. Key Accountabilities/Responsibilities 主要工作职责 Strategic Leadership and Execution Develop and implement local regulatory strategies for the TA portfolio, ensuring alignment with global regulatory strategies and cross-functional objectives (e.g., Development, Commercial, Medical). Deliver timely and high-quality regulatory submissions in alignment with GSK KPIs, processes, and compliance standards. Ensure regulatory excellence for submissions, labelling, and approvals, maintaining a "right-first-time" approach. Provide strategic prioritization, resource allocation, and operational oversight to ensure successful execution of regulatory projects. Lead risk assessments for RA projects and provide expert input on regulatory precedence and product characteristics to optimize decision-making. Stakeholder Engagement and Advocacy Build strong relationships with internal stakeholders, including Global Regulatory Affairs and cross-functional teams, to ensure alignment and support for regulatory strategies. Represent China RA in global Regulatory Management Team (RMT) meetings, ensuring the development and implementation of China-specific regulatory strategies. Provide high-quality, evidence-based regulatory input to TA/CRMT leads, supporting decision-making for key development questions and projects. External Engagement and Compliance Establish and maintain effective communication channels with China Health Authorities (e.g., CDE) to advocate GSK’s position and secure approvals for regulatory submissions. Lead advocacy initiatives to shape evolving legislation and regulatory requirements, collaborating with internal and external experts. Ensure compliance with all applicable regulations and standards for the TA portfolio, mitigating risks proactively. Team Leadership and Development Build and lead a high-performing RA TA team that meets current and future business needs, fostering a culture of excellence and collaboration. Drive personal and professional development for team members through structured training, talent reviews, and succession planning. Provide leadership as part of the LOC Regulatory Leadership Team (LT), contributing to objective setting, governance, budgeting control, and staff development. Qualifications/Requirements (Education / Experience / Competencies) 申请资格 / 职位要求 ( 教育背景 / 工作经验 / 知识与技能 ) Education & Experience Master’s degree or PhD are preferred in Life Sciences, Pharmacy, or related fields. Extensive experience in Regulatory Affairs, including senior leadership roles in multinational organizations. Proven track record in managing specific TA portfolios and engaging effectively with regulatory authorities. Experience in working across diverse, multicultural teams and matrix environments. Core Competencies Advanced knowledge of China’s regulatory landscape, including policies, personnel, and practices. Deep understanding of drug development processes and regulatory frameworks affecting the pharmaceutical industry. Proven success in obtaining product approvals and maintaining regulatory compliance. Strong analytical skills and ability to interpret complex regulatory documents. Strategic foresight to anticipate regulatory challenges and craft effective solutions. Exceptional project leadership and operational management capabilities. Ability to influence and manage cross-functional engagements, fostering consensus and collaboration. Proactive approach to monitoring regulatory changes and advocating for GSK’s position. Prioritization and multitasking in fast-paced, dynamic environments. Expected Behaviors Act decisively, challenge the status quo, and inspire ambition within teams. Follow through on commitments, uphold high standards, and drive continuous improvement. Foster personal growth and actively support team development to build future leaders. Collaborate effectively, challenge constructively, and align behind GSK’s purpose and values.