高级主任, 政府注册事务

Merck Sharp & Dohme Corp

Multiple Locations, China
Not specified
Bachelor's degree in biosciences
3+ years regulatory affairs experience
Familiarity with china veterinary drug regulations
Merck Sharp & Dohme Corp is seeking a Senior Executive in Regulatory Affairs to ensure timely approvals and compliance management for new chemical products in China. The role requires a strong background in regulatory affairs, particularly concerning veterinary drug regulations, and emphasizes problem-solving, clarity in communication, and collaborative teamwork

Job Summary

  • The role ensures timely approvals and compliant launches of new chemical entities through high-quality, no-delay submissions.
  • Candidates must provide clear, actionable regulatory guidance to R&D and commercialization teams while monitoring regulatory changes.
  • The position requires strong problem-solving skills to identify critical issues, perform structured analysis, and drive closure with captured learnings.

Matching Summary

Match Score: 85

Merck Sharp & Dohme Corp is seeking a Senior Executive in Regulatory Affairs to ensure timely approvals and compliance management for new chemical products in China. The role requires a strong background in regulatory affairs, particularly concerning veterinary drug regulations, and emphasizes problem-solving, clarity in communication, and collaborative teamwork.

Skills & Requirements

Must-have

  • Bachelor's degree in biosciences
  • 3+ years regulatory affairs experience
  • Familiarity with China veterinary drug regulations
  • eCTD submission preparation
  • Lifecycle compliance management

Nice-to-have

  • Experience in accelerated approvals
  • Complex project registration experience
  • Process optimization skills
  • Knowledge management experience
  • Strong analytical and logical thinking

Key Requirements

  • Bachelor's degree or above in biosciences
  • Minimum 3 years in regulatory affairs
  • Familiarity with China veterinary drug regulations and review practices

Work Rights

Not specified

Tailored Resume

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