Responsibilities
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 provide CMC regulatory assessment and strategy by working with regulatory and project leads
- Develop network with pharmaceutical industrial associations and participate in CMC initiatives and task forces
Requirements
- MS or PhD degree in chemistry, biology, or related scientific disciplines; Advanced degree is preferred.
- Expertise in CMC areas such as chemistry, formulation and analytical, at least 6 years of R&D, manufacturing, and/or regulatory experience.
- Knowledge in CMC regulatory requirements and ICH guidelines.
- Good oral and written communication skills in both English and Chinese.
- Proven ability in cross-functional cooperation, alignment and ownership in problem solving.