Senior APAC Submissions Publishing Specialist

MSD; Petaling Jaya; Hybrid; MYR 120,000 - 180,000; Full time

Job summary

MSD is seeking a Senior Specialist, Regional Submission Publishing to drive day-to-day regulatory submission publishing across the APAC region. You will ensure timely, accurate, and agency-compliant dossiers, working with cross-functional teams and regional colleagues to support priority submissions.

You will contribute to publishing workflow improvements, maintain templates and documentation, provide hands-on system support, and participate in testing of updates within GRACS RIIM and related

Qualifications

• Bachelor’s degree in science, IT or Pharmacy is required.

Responsibilities

• Execute day-to-day publishing activities for priority and lifecycle submissions, delivering high-quality, agency-compliant regulatory dossiers.
• Contribute to continuous improvement of publishing workflows and maintain region-specific documentation and checklists.
• Support complex submissions under guidance, building exposure to cross-functional coordination.
• Provide hands-on technical support and training on dossier structures and electronic submission requirements.
• Support publishing system usage, applying established processes and escalating issues.
• Participate in testing and adoption of publishing process changes.
• Provide guidance on publishing best practices to peers.
• Maintain records and provide status updates on publishing activities.
• Stay aware of regulatory procedures and industry practices; elevate impacts as needed.

Skills

Adaptability

Biotechnology

Compliance activities

Detail-oriented

Domestic policy

Pharmaceutical regulatory affairs

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 to drive day-to-day regulatory submission publishing across the APAC region. You will ensure timely, accurate, and agency-compliant dossiers, working with cross-functional teams and regional colleagues to support priority submissions.

You will contribute to publishing workflow improvements, maintain templates and documentation, provide hands-on system support, and participate in testing of updates within GRACS RIIM and related