Senior Director, Ap Regional Regulatory Operations
medhunter.de
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 oversee all Regulatory Operations activities in the Asia-Pacific region to deliver high-quality, timely regulatory submissions
Job Summary
The Senior Director will oversee all Regulatory Operations activities in the Asia-Pacific region to deliver high-quality, timely regulatory submissions.
This role serves as a critical partner with Regional Regulatory Teams to meet business objectives while driving strategic direction for the group.
The position involves managing a department of colleagues including planning, publishing, international labeling support, and systems process staff across approximately 23 countries.
Matching Summary
The Senior Director will oversee all Regulatory Operations activities in the Asia-Pacific region to deliver 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
Regional regulatory operations leadership
Cross-functional team collaboration skills
Nice-to-have
PMP or Sigma project management certification
RAPS certification or regional experience
Advanced degree in engineering or MBA
Fluency in regional specific languages
Experience with eCTD implementations
Key Requirements
Bachelor's degree in scientific discipline required
Minimum 8-10 years experience in Regulatory Affairs
Deep understanding of regional submission standards