APAC Regional Submission Publishing Expert

MSD Malaysia; Makati; On-site; PHP 5,967,000 - 8,794,000; Full time

Job summary

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, seeks a Senior Specialist for Regional Submission Publishing in APAC. You will execute publishing activities, collaborate with Regulatory Affairs and regional teams, and support system enhancements to ensure compliant, timely dossiers.

The role focuses on day-to-day publishing operations, coaching peers, and maintaining documentation within global frameworks.

Qualifications

• Bachelor’s degree in a science, IT or Pharmacy field is required.
• 3+ years in Regulatory Affairs, Regulatory Operations, or Submission Publishing in APAC.

Responsibilities

• Execute day-to-day publishing activities for priority and lifecycle submissions with high accuracy.
• Support publishing workflows, templates, and documentation within regional/global frameworks.
• Provide hands-on training and guidance on dossier formats, electronic submissions, and transmission.
• Collaborate with cross‑functional teams to ensure timely submission readiness.

Skills

Adaptability

Audits Compliance

Biotechnology

Pharmaceutical Regulatory Affairs

Regulatory Compliance

Publishing

Regulatory Documentation

Project Management

Information Technology (IT)

Knowledge Sharing

Regulatory Affairs Management

Regulatory Communications

Education

Bachelor’s degree in Science/IT/Pharmacy

Tools

Liquent Insight Publisher

Lorenz DocuBridge

RIIM systems

Job description

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, seeks a Senior Specialist for Regional Submission Publishing in APAC. You will execute publishing activities, collaborate with Regulatory Affairs and regional teams, and support system enhancements to ensure compliant, timely dossiers.

The role focuses on day-to-day publishing operations, coaching peers, and maintaining documentation within global frameworks.