在羅氏，我們鼓勵每位同事展現真實的自己；我們欣賞獨特且出眾的品質。羅氏的文化鼓勵積極的表達、開放的對話和真誠的連結，在這里，你將因為做自己而被重視、接納和尊重，并得到個人的提升和職業的發展。所有的這一切，都是為了更好地預防、阻止和治愈疾病，并確保醫療資源的可及性和可持續性。歡迎加入羅氏，一個重視每種聲音的地方。
職位
● Execute eCTD submission activities (including but not limited to planning, coordination, compilation, publishing, submissions of regulatory applications) in line with submission/content strategy in compliance with internal processes external regulations, to ensure high quality timely submission with Health Authority.
● Support contribute to the full adoption of eCTD submissions, to ensure fulfillment of evolving agency requirements corporate standards, including but not limited to system testing integration, tool enhancement, pilot submissions delivery.
● Contribute to eCTD capability building by setting up eCTD submission readiness in terms of infrastructure, process, etc. exploring optimal working models in terms of collaborations with multiple business partners (including but not limited to vendors, Global teams, stakeholders).
● Provide eCTD training support knowledge management to relevant colleagues, teams stakeholders fnecessary understanding of eCTD requirements to ensure smooth collaborations from a cross-functional perspective fsubmission excellence.
● Stay updated on the latest regulatory regulations, guidelines changes; interpret foresee the impact on corporate practice process with proactive mitigation applicable solutions.
● Contribute to vendoversight fexcellent delivery with optimized model process.
● Support the development implementation of the strategic plans feCTD submissions in alignment with theganization’s portfolio priorities.
● Support the group leader on exploring new ways of working to achieve a high-performanceganization.

eCTD Expertise
● Solid knowledge of regulatory agency requirements felectronic submissions format delivery including profuse knowledge of eCTD specifications validation requirements.
● Practical hands-on experiences in executing eCTD applications involving the assembly, formatting, publishing submissions of regulatory dossiers with HAs.
● Expertise in eCTD publishing process tools, submission software, documents management systems; proficiency with relevant IT tools, especially MS Office programs (Word, Excel) 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 the ability to identify opportunities fprocess improvement.
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● Ability to effectively plan, execute, monitprojects from initiation to completion with minimum guide.
● Capability to collaborate with diverse stakeholders to ensure alignment support, by building maintaining trustful strong relationships, proactively managing stakeholder expectations, with strong interpersonal communication skills to influence negotiate effectively.
● Ability to work effectively within a team across departments to achieve common goals, by developing cultivating robust relationships with colleagues at all levels of theganization, fostering a collaborative work environment inclusively, supporting team members by sharing knowledge providing technical-shooting assistance/insights inputs, etc. ● A strong commitment to continuous learning self-improvement, with a demonstrated ability to quickly manage usage of new systems tools, acquire new knowledge skills, adapt to changing environments, stay updated with industry trends best practices; the ability to learn from feedback incorporate it personal professional growth.
Education/Qualifications ● B.S. above in Pharmacy, Medical, Biology 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 PC Skills: ● Chinese (mother-tone level) English (proficiency level) ● Digital mindset 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. Fthis 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.

我們是誰
打造更健康的未來是促使我們創新的動力。全球超過100,000名員工共同致力于推進科學，確保今天和明天的人們，都能獲得高質量的醫療資源。我們的努力幫助了2600多萬人使用我們的藥物進行治療，我們的診斷產品運行超過300億次檢測。羅氏通過賦能探索新的可能、激發創造力并保持高標準以提供突破傳統的醫療解決方案，對全球的醫療環境帶去推動和影響。

讓我們一起，構建更健康的未來。

羅氏提供平等的職業發展機會。