Key Responsibilities

• Ensure the consistency and integrity of CMC data throughout the product lifecycle, from drug development to NDA/BLA approval

• Establish CMC roadmaps and oversee overall timelines throughout the drug development lifecycle

• Conduct technical reviews and centralize the management of generated CMC data

• Lead the preparation and authorship of CTD Module 3

Major Role

• Overall management of CMC timelines

• CMC gap analysis and remediation

• Lead the authorship of CTD Module 3 and manage regulatory submission readiness

Qualifications

[Requirement]

• Bachelor's degree or higher in Life Sciences, biological sciences, Chemistry, or Pharmacy

• General understanding of end-to-end CMC development and commercialization

• Excellent proficiency in English

[Preferred Qualification]

• 5+ years of experience in the drug development industry

• Experience authoring CTD Module 3 and supporting inspections/audits by domestic and international regulatory agencies (e.g., FDA, EMA)

• Experience establishing CMC timelines, including all required CMC activities from product development to BLA submission

• Experience drafting Process Validation Master Plans (PVMP), covering detailed activities from Process Design, PPQ, and CPV

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