Regulatory Affairs Specialist - Submission Management

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.

The Position

Your Opportunity

Operational Excellence

• Ability to execute tasks like document formatting /quality checks /tracking/ publishing/ compiling with supervision while learning project planning and management basics.

• Demonstrates potential to build trustful relationships with colleagues and stakeholders to support submission processes through communication and basic coordination.

• Works effectively within a team by participating in collaborative efforts, contributing ideas, and asking for help as needed to achieve common goals.

• Strong commitment to learning and adapting with guidance, including acquiring familiarity with new systems, tools, and workflows to foster personal and professional growth.

Who You Are

eCTD Expertise

• Foundational understanding of eCTD submission format and regulatory requirements, with a focus on learning NMPA-specific guidelines and terminology in parallel to those of ICH, FDA, EMA, etc.

• Familiarity with documentation assembly and formatting, working under supervision to gain practical experience in eCTD compilation and validation.

• Essential knowledge to eCTD publishing processes, submission software, document management systems, and MS Office and Adobe Acrobat for document preparation; exposure to systems like RIM/Veeva Vault as part of training.

• A proactive, motivated learner eager to understand regulatory changes and contribute to process improvement under guidance.

Who we are

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.