Senior Director, Ap Regional Regulatory Operations

Merck Sharp & Dohme Corp

Singapore, Singapore
Hybrid
8-10 years regulatory affairs experience
Submissions planning and publishing expertise
Local labeling and artwork support management
The Senior Director of AP Regional Regulatory Operations at Merck Sharp & Dohme Corp in Singapore is responsible for overseeing regulatory operations activities within the Asia-Pacific region, ensuring high-quality and timely submissions to health authorities. The role requires extensive experience in regulatory affairs, leadership capabilities, and strategic insight to navigate a complex regulatory landscape

Job Summary

  • This role leads all Regulatory Operations activities across the Asia-Pacific region to ensure high-quality, timely regulatory submissions.
  • The Senior Director will drive strategic direction for a department managing submission planning, publishing, and local labeling for approximately 23 countries.
  • Candidates must possess deep knowledge of regulatory submission standards and proven experience leading cross-functional teams in a fast-paced environment.

Matching Summary

Match Score: 85

The Senior Director of AP Regional Regulatory Operations at Merck Sharp & Dohme Corp in Singapore is responsible for overseeing regulatory operations activities within the Asia-Pacific region, ensuring high-quality and timely submissions to health authorities. The role requires extensive experience in regulatory affairs, leadership capabilities, and strategic insight to navigate a complex regulatory landscape.

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

  • Project management methodologies like PMP or Sigma
  • RAPS certification or regional regulatory knowledge
  • 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
  • Minimum 8-10 years Regulatory Affairs experience
  • Deep understanding of drug development landscape
  • Proven ability to lead cross-functional teams

Work Rights

Not specified

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