Job Description

What you will be working on:

Evaluate Chemistry, Manufacturing and Controls (CMC) data of post-approval variation applications for therapeutic products, provide recommendations for regulatory decisions, and process applications within the targeted timeline.

What we are looking for:

  • Possess knowledge/relevant experience in Chemistry, Molecular Biology, Biochemistry, Pharmacy or related disciplines.
  • Experienced in pharmaceutical manufacturing and quality control of biologics and/or chemical drug products.
  • Specific Skills:
    • Knowledge of chemistry and manufacturing of pharmaceuticals
    • Knowledge of drug development process and drug regulations
    • Knowledge of international regulatory guidelines
    • Good communication and interpersonal skills
    • Able to work independently, as well as in a team
    • Able to work effectively with people from different background
    • Highly motivated with strong desire...

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