(Asso.) Manager, CMC RA

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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