Regulatory Publishing Manager I

Role Purpose职位目标

• The Regulatory Publishing Manager I 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 oversight 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 proactive identification, assessment, and resolution of complex publishing challenges, including technical, operational, and regulatory issues that may impact submission quality or timelines. The role evaluates potential risks, develops mitigation strategies, and drives continuous improvement initiatives during publishing process to enhance publishing efficiency, quality, and compliance. Strong collaboration with central and local cross-functional stakeholders 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. Through effective planning, governance, and stakeholder engagement, the role ensures that regulatory system configurations consistently meet China regulatory requirements while maintaining alignment with global regulatory expectations, supporting business continuity and organizational objectives.
• Perform and optimize regulatory publishing operations for China eCTD and eSubmission, including formatting, publishing, and validation activities, providing expert guidance to the submission component owners, ensuring robust compliance with health authority regulations, internal standards, and global publishing best practices. Drive timely delivery of high-quality dossiers by proactively identifying risks, resolving complex publishing issues, and ensuring technical compliance through review, continuous improvement, and verification. Act as a key contributor in assessing the regulatory impact and operational feasibility of new or updated eCTD regulations.
• 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. Act as a liaison between the central and local teams by cascading publishing and system-related communications, updates, policy changes, and new initiatives to the appropriate local stakeholders, ensuring alignment, awareness, and effective execution across the organization. Provide training, guidance, and day-to-day support to regulatory affairs staff on publishing requirements and the effective use of RIM system.

Key Accountabilities/Responsibilities
主要工作职责

• Perform and optimize regulatory publishing operations for China eCTD and eSubmission, including formatting, publishing, and validation activities, providing expert guidance to the submission component owners, ensuring robust compliance with health authority regulations, internal standards, and global publishing best practices. Drive timely delivery of high-quality dossiers by proactively identifying risks, resolving complex publishing issues, and ensuring technical compliance through review, continuous improvement, and verification. Act as a key contributor in assessing the regulatory impact and operational feasibility of new or updated eCTD regulations.
• 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. Act as a liaison between the central and local teams by cascading publishing and system-related communications, updates, policy changes, and new initiatives to the appropriate local stakeholders, ensuring alignment, awareness, and effective execution across the organization. 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.
• Experience:
• Solid experience in regulatory affairs within the pharmaceutical industry. Direct 5 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.
• Ability to independently manage publishing activities and resolve complex publishing-related issues.

• Skills: Veeva Publishing, Veeva RIM, MS Office, Adobe Acrobat.