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 management responsibilities, budget ownership, or accountability for regional strategy.
Education
• Bachelor’s degree in a science, information technology or Pharmacy discipline required.
Required
• Minimum 3 years of experience in Regulatory Affairs, Regulatory Operations, or Submission Publishing, with demonstrated hands‑on experience supporting regulatory submission publishing activities within the APAC region.
• Strong operational experience in submission publishing, including preparation, compilation, validation, transmission, and archiving of electronic regulatory dossiers in compliance with regional agency requirements.
• Working knowledge of publishing systems and tools, such as Liquent Insight Publisher and/or Lorenz DocuBridge, and familiarity with Regulatory Innovation and Information Management (RIIM) systems used in publishing and adjacent regulatory processes.
• Solid understanding of regional regulatory submission requirements, including dossier structures, electronic submission formats, and agency transmission methods (e.g., agency gateways and repositories).
• Demonstrated ability to execute multiple publishing activities concurrently, effectively prioritizing day‑to‑day tasks to meet submission timelines in a fast‑paced, matrix environment.
• Strong attention to detail and quality mindset, with the ability to identify issues, follow established processes, and escalate risks appropriately to ensure compliant and accurate submission outputs.
• Effective communication and collaboration skills, enabling productive interaction with cross‑functional stakeholders, regional publishing colleagues, and vendors involved in submission execution.
• Experience contributing to continuous improvement initiatives across publishing workflows, templates, documentation, and system usage, and delivering technical guidance or training on publishing systems, dossier formats, electronic submissions, and transmission processes to peers or less‑experienced colleagues.
Language
• Fluent in English and a regional Language, if applicable.
Required Skills: Adaptability, Adaptability, Audits Compliance, Biotechnology, BuildMaster, Compliance Activities, Detail-Oriented, Domestic Policy, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Information Technology (IT), Knowledge Sharing, Legal Compliance, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Publishing, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Documents, Regulatory Experience, Regulatory Management {+ 7 more} Preferred Skills:
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Employee Status: Regular Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements: Hybrid Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date: 10/19/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.