Manager, Cmc

Merck & Co., Inc.

China
Not specified; not specified; not specified
Cmc regulatory requirements knowledge
Ich guidelines expertise
English and chinese communication skills
Lead Regulatory CMC Policy & Intelligence efforts to navigate the regulatory landscape and advocate for strategic policy objectives

Job Summary

  • Lead Regulatory CMC Policy & Intelligence efforts to navigate the regulatory landscape and advocate for strategic policy objectives.
  • Act as the primary representative for CMC issues, coordinating submissions and interactions with Health Authorities in China and HQ teams.
  • Provide technical CMC expertise to support drug development stages including clinical trials, NDA, and post-approval variations.

Matching Summary

Lead Regulatory CMC Policy & Intelligence efforts to navigate the regulatory landscape and advocate for strategic policy objectives.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • CMC regulatory requirements knowledge
  • ICH guidelines expertise
  • English and Chinese communication skills
  • Chemistry, formulation, or analytical background
  • 3-5 years R&D or regulatory experience

Nice-to-have

  • Proactive teamwork spirit
  • Detail-oriented approach
  • Experience with industry associations
  • Global stakeholder collaboration

Key Requirements

  • BS, MS, or PhD in chemistry, biology, or related field
  • 3-5 years of R&D and/or regulatory experience
  • Fluency in English and Chinese oral and written communication

Work Rights

Not specified

Tailored Resume

Cover Letter