Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

Primary duties and responsibilities

• Maintain end to end registration testing process and strategy. Oversight registration testing progress across products. Identify opportunities and continuously optimize the process
  
• Maintain assigned registration testing sub-processes and strategy, e.g., samples ordering and shipment
  
• Proactively identify common challenges to registration testing, and lead cross-team strategic alignment for assigned topics with internal stakeholders.
  
• Single point of contact for CMC topics and issues related to China submission for a specific product.
  
• Lead strategic alignment for selected Rt Q common challenges identified across products. Support project teams to review Rt Q responses where applicable
  
• Support CMC Excellence lead to oversight assigned internal processes, e.g., GMP certificates ordering, POA ordering. Provide hands-on support where vital.
  

Who you are
Educations

• Bachelor’s Degree or equivalent experience or above in relevant technical area (Analytical, Biochemistry, Biology). Master's degree or equivalent experience is preferred.
  

Experience

• At least 2 years work experiences in analytical, CMC, or RA area.
  
• Small molecular physical & chemical testing experience is preferred. Registration testing experience is a plus.
  
• Experience in Regulatory Affairs with focus on CMC requirements for small molecule/biologic products, development, manufacturing and/or quality assurance experience is a plus.
  

Knowledge/Skills/Competencies

• Demonstrates effective problem-solving ability, shows excellent interpersonal skills and has the ability to prioritize multiple tasks
  
• Strong knowledge of pharmacopoeia (Ch P, USP, EP), China regulations and guidance. Knowledge of regulations and guidelines of other major markets (e.g. FDA, EMA) is a plus
  
• Has proven track record to influence and work both independently and collaboratively in a team structure
  
• Strong verbal and written communication skills
  
• Proficient in English and Chinese
  

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.