Regulatory Publishing Associate Manager

Role Purpose职位目标

• The Regulatory Publishing Associate Manager is responsible for ensuring the timely delivery of compliant, high-quality electronic publishing activities that fully align with health authority regulations, China-specific requirements, and applicable global standards. This role provides operation support for end-to-end regulatory publishing activities throughout the entire product lifecycle, from initial submissions to renewals and lifecycle maintenance. With clear accountability for supporting patient safety, regulatory compliance, and uninterrupted product supply, the role ensures that the published regulatory dossiers are accurate, complete, and submission-ready.

• The role requires support to resolve and escalate complex publishing challenges, including technical, operational, and regulatory issues that may impact submission quality or timelines. Strong collaboration with central and local cross-functional stakeholders during publishing process is essential to align submission strategies, manage evolving regulatory requirements, and ensure successful execution of regulatory objectives.

• The role also serves as a subject matter expert for the regulatory information management system, providing guidance and support to project teams and stakeholders. The role supports the regulatory system configuration consistently to meet China regulatory requirements while maintaining alignment with global regulatory expectations, supporting business continuity and organizational objectives.

Key Accountabilities/Responsibilities
主要工作职责

• Perform regulatory publishing operations for China eCTD and eSubmission, including formatting, publishing, and validation activities, ensuring robust compliance with health authority regulations, internal standards, and global publishing best practices. Ensure timely delivery of high-quality dossiers by proactively identifying risks, escalating publishing-related issues and challenges, and ensuring technical compliance through review, continuous improvement, and verification.

• Lead the planning and tracking of publishing milestones for assigned activities, and take ownership of the early identification, communication, and escalation of issues that may jeopardize publishing timelines and deliverables.
• Support publishing system compliance by following processes and documentation requirements that ensure audit readiness, data integrity, and operational excellence.

• Collaborate closely with cross-functional teams and stakeholders to monitor regulatory information management system readiness, identify potential risks, resolve operational issues. Provide training, guidance, and day-to-day support to regulatory affairs staff on publishing requirements and the effective use of RIM system.

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, majored in life sciences, pharmacy, medicine, or a related discipline.

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• Experience:

• Solid experience in regulatory affairs within the pharmaceutical industry. Direct 3 years’ experience in China eSub and eCTD publishing will be preferred.

• Proven track record of cross-functional collaboration (e.g., Medical, TA, CMC, IT) to deliver integrated publishing outputs.
• Experience in identifying, assessing, and mitigating publishing and RIM system related compliance risks.
• Skills: Veeva Publishing, Veeva RIM, MS Office, Adobe Acrobat