Regional Submission Publishing Senior Specialist
Merck
Merck seeks a Senior Specialist in Regional Submission Publishing to execute regulatory dossier preparation, compilation, and transmission across the Asia-Pacific region. The role focuses on day-to-day publishing operations, system support, process improvement, and technical guidance within established regulatory frameworks.
Responsibilities
- Execute day-to-day publishing activities for priority and lifecycle submissions in compliance with agency standards
- Collaborate with Regulatory Affairs, CMC, and regional teams to resolve publishing operational issues
- Identify workflow inefficiencies and propose improvements within regional and global frameworks
- Provide technical support and training on dossier structures, electronic submissions, and publishing tools
- Maintain accurate operational records and communicate status updates on publishing activities
Requirements
- Bachelor's degree in science, information technology, or pharmacy
- Minimum 3 years regulatory affairs, operations, or submission publishing experience in APAC
- Hands-on experience preparing, validating, transmitting, and archiving electronic regulatory dossiers
- Proficiency with publishing systems such as Liquent Insight Publisher or Lorenz DocuBridge
- Solid knowledge of regional regulatory submission requirements and electronic submission formats
- Ability to manage multiple publishing tasks concurrently and meet submission deadlines
- Strong attention to detail, communication, and cross-functional collaboration skills
Vacancy posted a month ago
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