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.

Roche Diagnostics

Main Responsibilities:

Managing local regulatory plan in cooperation with other internal stakeholders to ensure our products are registered on timely manner and business objectives are met

Submitting technical documentation to Regulatory Authorities and securing registration approval in a timely manner

Maintaining product registration throughout a product’s lifecycle by applying appropriate regulatory change control.

Providing Global RA with real-time information required to maintain key metrics (i.e. submission dates and approval dates for all product registrations)

Monitoring and communicating new, upcoming & changes to regulations with local stakeholders and Global RA

Influencing / shaping regulatory landscape/regulations where possible (“advocacy”)

Requirements:

A minimum of a B.S. degree in biomedical science, life science or related field, with 2-3 years health-related quality-focused and regulatory experience 

Knowledge of diagnostics is preferable.

Strong interpersonal communication skills.

Self-starter, highly motivated with attention to details

Excellent command of written and spoken English and Chinese

Must be able to work independently, by taking general concepts and direction to produce desirable compliant outcomes.

Ability to prioritize multiple tasks and to function effectively.

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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.