Senior Director, Ap Regional Regulatory Operations
Merck & Co., Inc.
Singapore, Singapore
Not specified; not specified; not specified
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 while managing a department responsible for submission planning, publishing, and local labeling support.
The position requires driving continuous improvement of business processes and systems while navigating complex regulatory environments across approximately 23 countries.
Matching Summary
The Senior Director will lead all Regulatory Operations activities across the Asia Pacific region to ensure high-quality, timely regulatory submissions.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
8-10 years Regulatory Affairs experience
Submissions planning and publishing expertise
Local labeling and artwork support management
Cross-functional team leadership in matrix org
Deep knowledge of AP regional regulatory standards
Nice-to-have
PMP or Sigma project management certification
RAPS certification or in-region experience
Advanced degree in engineering or MBA
Fluency in specified regional languages
Experience with eCTD and digital initiatives
Key Requirements
Bachelor's degree in scientific discipline required