CMC Sr. Manager/Associate Director

Responsibilities：

• Take CMC lead for products under clinical development and formarketed drug products. Coordinatevarious aspects of CMC regulatory activities with internal and external stakeholders. Act as a primary representative internally and externally for CMC related issues.
• Provide CMC expertise to support drug development at various stages including clinical trial application, NDA and subsequent variations
• Lead the communication with Global 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 onRQS,QC 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

Required：

• BS, MS or PhD degreein chemistry, biology, or related scientific disciplines;
• Expertise in CMC areas such as formulation and analytical, at least 5 years of R&D and/orregulatory experience;
• Knowledge in CMC regulatory requirements and ICH guidelines
• Excellent oral and written communication, interpersonal and influencing skills;
• Proven ability in cross-functional cooperation, alignment and ownership in resolving issues;