fa jobs (salary & requirements)

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
Job Summary:
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Products fthe respective area of responsibility shall obtain Regulatory approvals in defined markets in close cooperation with other functions.
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The documents/deliverables fsubmissions are coordinated compiled in a timely manner to support planned product registration timelines.
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The obtained Regulatory approvals/licenses products are maintained throughout the life cycle of the product by applying successful Regulatory change controls.
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The efficiency the success of the Regulatory activities strategies are maintained by clear agreements with other functions, stakeholders external partners (authorities, companies, NBs etc).
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The regulatory requirements strategic aspects are understood, communicated implemented, kept up to date are transparent within theganization.
Main Tasks & Responsibilities:
1. Regulatory document submission compilation:
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Oversees the development of submission/product registration dossiers of more complex products/programs. Develops manages at least parts of comprehensive global regulatory submissions registration plans. May act as mentfmore juniteam members in this area.
2. External interface management:
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Understands the structure, key roles responsibilities of external customers/stakeholders. Understands communicates timely effectively the needs of external customers/stakeholders. Builds effective enduring external relationships applies effective stakeholder management practices. Actively contributes to audits by supporting preparation, execution follow up.
3. Regulatory knowledge strategy:
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Leads theganization to adapt to evolving regulatory environment requirements.
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Experience in solving complex, critical health authority issues equivalent.
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Understanding of external environmental changes, precedents, to navigate complex situations influence strategies decision making.
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Ability to interpret apply understanding of the regulators thinking to projects apply strategies to the different needs of different regions without significant guidance.
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Proactively creates unique/innovative regulatory strategies influencing approaches to avoid regulatory obstacles accelerate worldwide approvals.
4. Stakeholder management influencing:
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Effectively partners with stakeholders to understprovide best solutions. Takes initiative to address problems opportunities involves stakeholders fbest solutions. Develops relationships that significantly influence the current future direction fRoche our products. Understands what motivates other people to perform at their best. Is skilled at managing influencing peers. Fosters an exchange of ideas amongst key stakeholders to be able to shift perspectives to reach a common agreeable outcome. Negotiates with stakeholders creates win-win compromises.
5. Decision making: :
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Has courage to make decisions even outside of scope/comfort zone.
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Proactively Initiates activities independently initiates interactions across departments as applicable. Embrace the good decision making principles. Pushes decision making to the lowest appropriate level. Commits to decisions that have been made. Shows good judgment in decision making. Makes good decisions without necessarily having all the information in a timely manner.
6. Innovation problem solving: :
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Drives innovation across theganization/sites. Advocates fhelps progress new ideas that add business value. Sees the value in others’ unique differences. Is entrepreneurial; seizes new opportunities. Works to drive new ideas the business.
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Able to troubleshoot issues as they arise, independently develop implement cost effective non-complex actions solutions to ensure that daily work is completed without jeopardizing compliance. Identifies problems before they occur actively drives mitigation strategies to avoid them. Leads others in problem-solving activities.
Requirements
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Bachelor’s degree in Life Science, Data Science related subject equivalent experience equivalent qualification fthe tasks has worked with many years of experience. Advanced degree is considered an advantage
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Preferred: Master degree in Life Science, Data Science related subject equivalent experience equivalent qualification fthe tasks has worked with many years of experience. Advanced degree is considered an advantage
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Fluent English
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6-8 years with Bacheldegree 5-7 years with Master’s degree in the field of IVDs/Medical devices with significant experiences in Regulatory Affairs equivalent
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Preferred: 8-10 years with Bacheldegree 6-8 years with Master’s degree in the field of IVDs/Medical devices with significant experiences in Regulatory Affairs equivalent
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Expertise Knowledge of the China regulations demonstrated ability to adequately interpret implement quality standards considered an advantage; Has demonstrated the ability to manage more complex work and/at least parts of global projects
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Preferred: Expertise Knowledge of the China, EU US demonstrated ability to adequately interpret implement quality standards considered an advantage; Has demonstrated the ability to manage more complex work and/at least parts of global projects
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。