APAC Regulatory Submissions Specialist – Publishing

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

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.