Specialist, Regional Submission Planner
Merck
Specialist responsible for planning and managing regulatory submission operations for the Asia-Pacific region within Merck's Global Regulatory Affairs and Clinical Safety organization. The role involves coordinating submission timelines, cross-functional collaboration, and regulatory compliance activities to support product registration and health authority approvals.
Responsibilities
- Plan and manage regulatory operation projects from authorization through delivery to country teams and Health Authorities
- Develop and maintain regulatory submission plans and project milestones for assigned products
- Facilitate cross-functional meetings and communication to coordinate submission planning and execution
- Drive submission assembly and delivery with Global and Regional Publishing teams to meet agreed timelines
- Identify process improvement opportunities and participate in efficiency enhancement initiatives
Requirements
- Bachelor's degree in Life Science, Pharmacy, or Engineering discipline
- Minimum 2 years pharmaceutical industry experience in operations, project management, or regulatory affairs
- Strong written and oral English communication skills
- Project management capabilities with ability to manage multiple timelines
- Knowledge of Asia-Pacific regulatory guidelines and procedures
- Proficiency with complex IT systems and regulatory databases
Vacancy posted 2 days ago
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