Senior Director, Ap Regional Regulatory Operations
Merck & Co., Inc.
Singapore, Singapore
Hybrid
8-10 years regulatory affairs experience
Submissions planning and publishing expertise
Local labeling and artwork support management
The Senior Director will lead all Regulatory Operations activities across the Asia-Pacific region to ensure high-quality, timely regulatory submissions
Job Summary
The Senior Director will lead all Regulatory Operations activities across the Asia-Pacific region to ensure high-quality, timely regulatory submissions.
This role serves as a strategic partner to global teams, driving process improvements and digital initiatives like e-Labeling and cloud-based submissions.
The position involves managing a diverse team of planners, publishers, and labeling specialists while fostering a high-performing organizational culture.
Matching Summary
The Senior Director will lead all Regulatory Operations activities across the Asia-Pacific region to ensure high-quality, timely regulatory submissions.
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 in-region experience
Advanced degree in engineering or science
Fluency in regional specific languages
Experience with eCTD implementations
Key Requirements
Bachelor's degree in scientific discipline required
Minimum 8-10 years Regulatory Affairs experience
Deep understanding of AP region regulatory standards