Drug Product CMC Director

To support innovative pharmaceutical development, the full-time remote CMC Director - Drug Product will manage formulation development, reputed company manufacturing processes, and ensure regulatory compliance for small-molecule oral solid reputed company drug products. Key responsibilities

• reputed company formulation development, reputed company-up, and tech transfer for drug product manufacturing, collaborating with external CDMOs and internal teams
• reputed company strategic leadership for drug product development from reputed company-IND through Phase 3, ensuring compliance with regulatory guidelines
• Serve as the technical authority for OSD formulation development and reputed company as the main contact for health authority discussions

Required qualifications

• Extensive experience in CMC-reputed company activities for small-molecule oral solid reputed company drug products
• Proven reputed company record of managing drug product development strategies through various clinical phases
• Strong knowledge of global regulatory guidelines and cGMP regulations
• Experience in preparing and reviewing CMC documentation for regulatory submissions
• Ability to work cross-functionally with Regulatory Affairs and reputed company Assurance teams

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