Regulatory Labelling Associate Manager

Role Purpose 职位目标 The Regulatory Labelling Associate Manager role ensures regulatory compliance, quality, and effective execution of product labelling activities in alignment with NMPA and applicable local requirements. The role manages end‑to‑end labelling development, maintenance, and implementation for assigned products across the lifecycle, applying sound professional judgment. Through accurate and timely execution, the role contributes to patient safety, regulatory compliance, and supply continuity, with errors or delays potentially leading to compliance risks or operational disruption. The role requires a diverse problem solving to manage labelling challenges within established regulatory frameworks, including evolving requirements, safety‑related updates, and cross‑functional operational constraints. The Labelling Associate Manager assesses regulatory impact and compliance risk, applies appropriate guidance, and supports resolution through coordination with Regulatory Affairs, Quality, Safety, and Supply Chain stakeholders. The role ensures that labelling decisions are appropriately implemented and documented, consistent with China regulatory requirements and aligned with global standards. Key Accountabilities/Responsibilities主要工作职责 Coordinate the end-to-end management of product labelling activities across the lifecycle, ensuring compliance with NMPA regulations and internal standards Ensure alignment of labelling with approved regulatory strategy, global standards, and evolving local requirements Lead cross-functional collaboration (RA, Safety, Quality, Supply, external partners) to deliver timely labelling updates Assess regulatory impact, compliance risk, and operational feasibility of labelling changes, with appropriate escalation Oversee execution and documentation of labelling updates, ensuring audit/inspection readiness and traceability Support health authority–driven labelling activities, including responses to regulatory queries and requirements Act as a subject matter expert for China labelling, providing technical guidance on routine and complex issues Drive continuous improvement of labelling processes, including workflow optimization and digital enablement Contribute to patient safety, product compliance, and supply continuity through accurate and timely labelling execution 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: Bachelor’s degree or above in life sciences, pharmacy, medicine, or a related discipline Solid scientific foundation to interpret complex regulatory and technical requirements Advanced degree preferred to support integration of clinical, CMC, and safety data into labelling decisions Experience: Solid experience in Regulatory Affairs within the pharmaceutical industry, with direct exposure to labelling development and maintenance Hands-on experience interpreting and implementing NMPA labelling regulations and ensuring compliant lifecycle management Demonstrated ability to manage labelling updates driven by regulatory changes, variations, and safety information Proven track record of cross-functional collaboration (e.g., Medical, Safety, CMC, Supply) to deliver integrated labelling outputs Experience in identifying, assessing, and mitigating labelling-related compliance risks Ability to independently manage labelling activities and resolve complex regulatory issues with sound judgment Skills: Strong knowledge of China regulatory requirements, particularly labelling regulations and compliance expectations Sound analytical and problem-solving skills to assess regulatory impact and make risk-based decisions Excellent cross-functional communication and stakeholder management skills High attention to detail with a focus on accuracy, consistency, and quality execution Ability to balance regulatory compliance, operational feasibility, and business needs Strong organizational skills with the ability to manage multiple priorities and timelines Continuous improvement mindset, including adoption of digital tools and process optimization Ability to work effectively in a global and cross-cultural environment