Associate Director, Regulatory Affairs

Lonza Group

Not specified
10 years industry experience in life sciences
Expertise in china nmpa and local ha regulations
Interpretation of cmc requirements for biologicals
Lonza Group is seeking an Associate Director of Regulatory Affairs to lead regulatory strategy development for China, ensuring compliance with local regulations and supporting product development efforts. The ideal candidate will have extensive experience in the regulatory landscape, particularly in biologicals, with a strong focus on communication and strategic project management

Job Summary

  • Lead the development and execution of regulatory strategies for China ensuring compliance with NMPA and Local HA regulations.
  • Act as the primary regulatory interface for Lonza ADS, establishing strong communications with Chinese Health Authorities.
  • Provide expert regulatory guidance to support product development, tech transfers, manufacturing changes, and lifecycle management.

Matching Summary

Match Score: 85

Lonza Group is seeking an Associate Director of Regulatory Affairs to lead regulatory strategy development for China, ensuring compliance with local regulations and supporting product development efforts. The ideal candidate will have extensive experience in the regulatory landscape, particularly in biologicals, with a strong focus on communication and strategic project management.

Skills & Requirements

Must-have

  • 10 years industry experience in Life Sciences
  • Expertise in China NMPA and Local HA regulations
  • Interpretation of CMC requirements for biologicals
  • Experience with mammalian fermentation processes
  • Established contacts with Chinese Health Authorities

Nice-to-have

  • Strategic approach to regulatory goals
  • Strong team leadership and talent development skills
  • Ability to represent company on regulatory issues
  • Excellent organizational and attention to detail skills

Key Requirements

  • Degree in Chemistry, Biochemistry, Biology, or Pharmacy
  • Minimum 10 years of industry experience
  • Demonstrated experience in Domestic and International Regulatory interactions

Work Rights

Not specified

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