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● Execute eCTD submission activities (including but not limited to planning, coordination, compilation, publishing, and submissions of regulatory applications) in line with submission/content strategy and in compliance with internal processes and external regulations, to ensure high quality and timely submission with Health Authority.
● Support and contribute to the full adoption of eCTD submissions, to ensure fulfillment of evolving agency requirements and corporate standards, including but not limited to system testing and integration, tool enhancement, pilot submissions delivery.
● Contribute to eCTD capability building by setting up eCTD submission readiness in terms of infrastructure, process, etc. and exploring optimal working models in terms of collaborations with multiple business partners (including but not limited to vendors, Global teams, stakeholders).
● Provide eCTD training and support knowledge management to relevant colleagues, teams and stakeholders for necessary understanding of eCTD requirements and to ensure smooth collaborations from a cross-functional perspective for submission excellence.
● Stay updated on the latest regulatory regulations, guidelines and changes; and interpret and foresee the impact on corporate practice and process with proactive mitigation and applicable solutions.
● Contribute to vendor oversight for excellent delivery with optimized model and process.
● Support the development and implementation of the strategic plans for eCTD submissions in alignment with the organization’s portfolio priorities.
● Support the group leader on exploring new ways of working to achieve a high-performance organization.
eCTD Expertise
● Solid knowledge of regulatory agency requirements for electronic submissions format and delivery including profuse knowledge of eCTD specifications and validation requirements.
● Practical hands-on experiences in executing eCTD applications involving the assembly, formatting, publishing and submissions of regulatory dossiers with HAs.
● Expertise in eCTD publishing process and tools, submission software, documents management systems; proficiency with relevant IT tools, especially MS Office programs (Word, Excel) and Adobe Acrobat; experience of working with RIM/Veeva Vault systems is a plus.
● Motivated self-starter with the sensitivity to detect potential impact raised by regulation change and the ability to identify opportunities for process improvement.
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● Ability to effectively plan, execute, and monitor projects from initiation to completion with minimum guide.
● Capability to collaborate with diverse stakeholders to ensure alignment and support, by building and maintaining trustful and strong relationships, proactively managing stakeholder expectations, with strong interpersonal and communication skills to influence and negotiate effectively.
● Ability to work effectively within a team and across departments to achieve common goals, by developing and cultivating robust relationships with colleagues at all levels of the organization, fostering a collaborative work environment inclusively, supporting team members by sharing knowledge and providing technical-shooting assistance/insights inputs, etc. ● A strong commitment to continuous learning and self-improvement, with a demonstrated ability to quickly manage usage of new systems and tools, acquire new knowledge and skills, adapt to changing environments, stay updated with industry trends and best practices; and the ability to learn from feedback and incorporate it into personal and professional growth.
Education/Qualifications • B.S. or above in Pharmacy, Medical, Biology or related field
Relevant working experience:
> 3 years’ experience in Pharma MNCs, including at least 2 years in regulatory submissions • Experience in delivering eCTD submissions is required • Independent working • Experiences in crisis management
Language and PC Skills: • Chinese (mother-tone level) and English (proficiency level) • Digital mindset and good computer skill/information management skill/project management skill
Travel Frequency <25%
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Beijing. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.
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.