Regulatory Affairs Officer – PD China

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

We are seeking a proactive Regulatory Affairs Officer to support China regulatory strategy and end-to-end execution for clinical development, product registration and lifecycle-management activities. You will work closely with global and China regulatory colleagues, cross-functional colleagues and China health authorities to help bring tmedicines to patients.

The Opportunity:

• Support the development and execution of China regulatory strategies, assessments and submission plans for clinical trials, new product registrations, line extensions and post-approval changes.
• Prepare, review and coordinate high-quality regulatory documentation and submission packages; track milestones and support timely responses to authority questions.
• Support communications, meetings and procedures with China health authorities, under appropriate guidance.
• Contribute to regulatory intelligence by monitoring evolving China and global regulatory requirements and sharing relevant insights with project teams.
• Maintain complete, accurate and inspection-ready regulatory records in line with applicable requirements, company policies and data-integrity standards.

Who you are:

• Bachelor’s degree or above in pharmacy, life sciences, medicine, chemistry or a related discipline.
• Background in pharmaceutical Regulatory Affairs (RA) or R&D; prior experience in regulatory affairs is strongly preferred.
• Working knowledge of China drug-registration requirements and an interest in keeping current with the evolving regulatory environment.
• Strong written and verbal communication skills in Chinese and English; able to prepare clear, accurate technical and regulatory documents.
• Strong sense of responsibility and ownership, effective project coordination skills, attention to detail and the ability to manage multiple priorities and timelines.
• Possess strong cross-functional collaboration skills, with a proven ability to effectively coordinate cross-departmental efforts and support team operations during project execution. 

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.