在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。
职位
● 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.
Operational Excellence Version date: Dec 2025 Page 1 of 2
● 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.
我们是谁
打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。
让我们一起，构建更健康的未来。
罗氏提供平等的职业发展机会。
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