Senior Director, Ap Regional Regulatory Operations
Merck & Co., Inc.
Singapore, Singapore
**
8-10 years regulatory affairs experience
Submissions planning and publishing expertise
Local labeling and artwork support management
**
The Senior Director, AP Regional Regulatory Operations at Merck & Co., Inc. is a leadership role focused on overseeing regulatory operations across the Asia-Pacific region. The ideal candidate will possess extensive experience in regulatory affairs, project management, and cross-functional team leadership, while contributing to the continuous improvement of business processes.
**
Job Summary
The Senior Director will oversee all Regulatory Operations activities in the AP region to deliver high-quality, timely regulatory submissions across the portfolio.
This role serves as a critical partner with Regional Regulatory Teams to meet business objectives while driving strategic direction for the group.
The position requires managing a department of colleagues including planning, publishing, international labeling support, and systems process staff across approximately 23 countries.
Matching Summary
Match Score: 75
**
The Senior Director, AP Regional Regulatory Operations at Merck & Co., Inc. is a leadership role focused on overseeing regulatory operations across the Asia-Pacific region. The ideal candidate will possess extensive experience in regulatory affairs, project management, and cross-functional team leadership, while contributing to the continuous improvement of business processes.
**
Skills & Requirements
Must-have
8-10 years Regulatory Affairs experience
Submissions planning and publishing expertise
Local labeling and artwork support management
Regional regulatory operations leadership
Cross-functional team collaboration
Nice-to-have
PMP or Sigma project management certification
RAPS certification or regional experience
Advanced degree in engineering or science
Fluency in regional specific languages
Experience with eCTD implementations
Key Requirements
Bachelor's degree in scientific discipline
Minimum 8-10 years Regulatory Affairs experience
Deep understanding of regional submission standards