Regional Submission Publishing Senior Specialist

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Job Description The Senior Specialist, Regional Submission Publishing is an individual contributor within the Regional Regulatory Operations – Asia Pacific (RRO AP) department, part of the company's Global Regulatory Affairs and Clinical Safety (GRACS) organization within the specific division. This role is responsible for the operational execution of regulatory submission publishing activities across the APAC region, ensuring timely, accurate, and agency‑compliant preparation, publishing, transmission, and archiving of regulatory dossiers. The Senior Specialist applies strong technical expertise in submission publishing systems, formats, and processes, and works closely with Regulatory Affairs, CMC, SPRI, and regional publishing colleagues to support assigned priority and lifecycle submissions within a defined operational scope. With a primary focus on day‑to‑day publishing operations, the role contributes to continuous improvement of publishing workflows and documentation within established regional and global frameworks, supports effective use of publishing systems and tools, and provides hands‑on technical support and ad‑hoc knowledge sharing to reinforce consistent and compliant submission execution across the region. All activities are performed under established procedures, defined governance, and within regional and global publishing frameworks. Primary Activities include but are not limited to: Execute day‑to‑day publishing activities for priority and lifecycle submissions, delivering high‑quality, agency‑compliant regulatory dossiers, and collaborate with RAI, iCMC, SPRI, GRACS O.P.S., and regional Regulatory Affairs teams to support submission readiness and resolve publishing‑related operational issues. Contribute to continuous improvement of publishing workflows by identifying operational issues and proposing updates within established regional and global frameworks, and maintaining region‑specific documentation, templates, job aids, and checklists to support regulatory compliance, operational efficiency, and alignment with evolving submission standards. Support selected complex, multi‑market, or priority submissions under guidance, building exposure to increased regional scope, cross‑functional coordination, and escalation‑based publishing decision‑making in support of professional development toward higher‑complexity regional roles. Provide hands‑on technical support and support training activities on dossier structures and formats, electronic submission requirements, transmission methods (e.g., agency gateways), publishing repositories, and related publishing tools, supporting consistent execution and capability uplift across the regional publishing team. Support the use of publishing systems and tools, including GRACS RIIM and related platforms, by applying established processes, identifying operational issues, escalating impacts, and contributing inputs for refinement or enhancement as required. Provide operational support for publishing system or process changes, including participation in testing, validation, and adoption activities, and applying updated procedures within day‑to‑day publishing work. Provide informal guidance on publishing best practices, system usage, and regulatory submission requirements to less‑experienced colleagues, without accountability for team performance, capability outcomes, or people leadership responsibilities. Maintain accurate operational records and provide status updates on publishing activities to support tracking, issue escalation, and continuous improvement across regional publishing operations. Maintain awareness of internal and external regulatory procedures, guidelines, and policies impacting Publishing, and apply this knowledge to day‑to‑day publishing activities. Monitor relevant regulatory updates and industry practices through self‑directed learning and escalate potential impacts as appropriate. This position is an individual contributor role, without formal people

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