Manager, CMC

Job Description

Take CMC lead for products under clinical development and for marketed drug products. Coordinate various aspects of CMC regulatory activities with internal and external stakeholders. Act as a primary representative internally and externally for CMC issues.

• Provide CMC expertise to support drug development at various stages including clinical trial application, NDA and post approval variations
• Lead the communication with HQ CMC and China RA teams to ensure high quality CMC submissions in compliance with China regulations and guidelines
• Act as a primary contact for CMC query response, lead and coordinate the response process between China and HQ teams, and interact with the agency for project related CMC issues
• Work with regulatory colleagues on specification, quality control testing and inspection for specific products; provide technical input and facilitate the discussion between China and HQ teams
• Participate in China project development teams to identify CMC needs by working with regulatory and project leads
• Develop network with pharmaceutical industrial associations and participate in CMC initiatives and task forces

Requirements

• BS, MS, or PhD degree in chemistry, biology, or related scientific disciplines; an advanced degree is preferred.

• Expertise in CMC areas such as chemistry, formulation, and analytical, 3~5 years of R&D and/or regulatory experience.

• Knowledge of CMC regulatory requirements and ICH guidelines.

• Good oral and written communication skills in both English and Chinese;

• Proactive and teamwork spirits

Required Skills:

Preferred Skills:

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