Regional Submission Publishing Senior Specialist

MSD; Makati; Hybrid; PHP 900,000 - 1,300,000; Full time

Job summary

MSD is seeking a Senior Specialist, Regional Submission Publishing in the APAC region to manage day-to-day regulatory dossier publishing activities, ensuring accuracy, timeliness, and compliance with agency requirements.

You will work closely with Regulatory Affairs, CMC, SPRI, and regional teams to support priority submissions, drive workflow improvements, and provide hands-on technical guidance on publishing systems and dossier formats.

Qualifications

• Minimum 3 years of experience in Regulatory Affairs, Regulatory Operations, or Submission Publishing with APAC exposure.
• Strong operational experience in submission publishing, including preparation, compilation, validation, transmission, and archiving of electronic dossiers.
• Knowledge of publishing systems and tools such as Liquent Insight Publisher and Lorenz DocuBridge; RIIM familiarity.

Responsibilities

• Execute day-to-day publishing activities for priority and lifecycle submissions, delivering high-quality, agency-compliant regulatory dossiers and collaborating with cross‑functional teams.
• Contribute to continuous improvement of publishing workflows by identifying issues and updating region-specific templates and checklists.
• Support complex, multi-market submissions under guidance, expanding regional exposure and coordination.
• Provide hands-on technical support and training on dossier formats, submissions, and transmission processes.
• Support use of publishing systems and RIIM platforms, applying established processes and contributing to refinements.
• Provide operational support for system/process changes, including testing and adoption activities.
• Offer informal guidance on best practices and regulatory requirements to peers.
• Maintain accurate records and provide status updates across regional publishing operations.
• Stay aware of regulatory updates and industry practices through self-directed learning.

Skills

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

Education

Bachelor’s degree in a science, information technology or Pharmacy discipline

Tools

Liquent Insight Publisher

Lorenz DocuBridge

RIIM systems

Job description

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 escalation 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 escalation 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}

Employee Status

Regular

Flexible Work Arrangements

Hybrid

Job Posting End Date

10/19/2026

Requisition ID

R416812