Regulatory Affairs Specialist at F. Hoffmann-La Roche Ltd - Poland

Beijing, Beijing, China -

Full Time

Start Date

Immediate

Expiry Date

21 Jun, 26

Salary

0.0

Posted On

23 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Document Formatting, Quality Checks, Tracking, Publishing, Compiling, Project Planning, Project Management, Communication, Coordination, Teamwork, eCTD Expertise, Regulatory Requirements, NMPA Guidelines, ICH, FDA, EMA

Industry

Biotechnology Research

Description

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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The specialist will execute operational tasks such as document formatting, quality checks, tracking, publishing, and compiling under supervision while learning basic project planning and management. They will also build relationships with stakeholders to support submission processes through communication and basic coordination.