欧盟法规事务经理
EU Regulatory Affairs Manager
### **职业类别**
监管事务
### **职位描述**
**你将如何超越想象？**
如果你觉得自己是更大事业的一部分，那是因为你是。在安进，我们的共同使命——服务患者——驱动我们所做的一切。这是我们成为全球领先的生物技术公司的重要因素。我们是全球合作伙伴，共同实现目标——研究、制造并提供不断改进的产品，惠及全球超过1000万患者。现在是时候开启一段让你自豪的职业生涯了。加入我们。
**欧盟监管事务经理**
**工作地点：现场**
**你将负责的工作**
在这个关键的职位中，你将确保安进获得并维持所有必要的欧盟许可，以支持试验性药品和已上市药品的临床试验。
你将从欧盟监管的角度支持一个或多个产品。
策略与执行
- 根据业务需求和经验，该职位可能包括一个或多个产品的欧盟监管负责人职责。
- 为安进产品组合中的产品制定并管理监管提交（例如临床试验和上市申请），符合全球提交计划和欧盟区域监管要求。
- 在一般监督下，根据欧盟区域法规和监管要求，实施与产品相关的监管策略、监管事务流程和活动计划。根据全球策略，为区域监管文件和会议提供内容指导。
- 为优化产品开发提供区域监管机制的监管指导（例如加速首次人体试验、科学建议、孤儿药、市场批准机制和儿科计划）。
- 支持欧盟标签谈判活动。
- 在一般监督下，参与区域监管产品策略的制定和执行。
- 在一般监督下，制定与监管机构结果相关的预期和风险预测。
监管研究
- 关注与安进产品相关的新的和正在发展的立法、监管政策和技术监管指南。
- 进行监管研究，获取与区域产品推进相关的历史记录、先例和其他相关信息。
- 在监督下评估并传达相关区域法规、指南、当前监管环境和竞争对手情况的影响。
查看英文原文
### **Career Category**
Regulatory
### **Job Description**
**HOW MIGHT YOU DEFY IMAGINATION?**
If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
**EU REGULATORY AFFAIRS MANAGER**
**LIVE**
**What you will do**
In this vital role you will work to ensure that Amgen acquires and maintains all the required EU licenses in order to support clinical trials for investigational medicinal products as well as marketed medicinal products.
You will support one or more products from an EU regulatory perspective.
Strategy and Execution
- Depending on business needs and experience, the role may include EU Regulatory Lead responsibility for one or more products.
- Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and EU regional regulatory requirements.
- Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with EU regional legislation and regulatory requirements. Provide content guidance for regional regulatory documents and meetings in accordance with global strategy.
- Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, scientific advice, Orphan Drug, MA approval mechanisms and paediatric plans).
- Support EU label negotiation activities.
- Under general supervision participate in the development and execution of regional regulatory product strategies.
- Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.
Regulatory Research
- Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
- Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
- Under supervision evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling.
**Be part of our team**
We are currently looking for x3 EU Regulatory Affairs Managers between Portugal and the United Kingdom, joining the EU Oncology or General Medicine teams, part of the Global Regulatory Affairs function in Europe.
You will be working with colleagues who are responsible for leading the European regulatory strategies and submissions for development and marketed products from first-in human clinical trials to marketing authorisation, and throughout the products lifecycle.
**WIN**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
- Degree educated and previous experience in a similar role
- Hands-on experience with registration procedures in the region, such as clinical trials, pre-MAA regulatory procedures (eg scientific advice, orphan applications or Paediatric Investigation Plans (PIPs)), MA, post-approval changes, extensions and renewals
- Experience developing regulatory strategies for products in clinical development and post-marketing phases.
- Knowledge of EU legislation and regulations relating to medicinal products
- Working with policies, procedures and SOP’s .
- Strong communication skills - both oral and written.
- Ability to anticipate and prevent potential issues.
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
- Basic proficiency in using AI tools to support day-to-day work.
**THRIVE**
**What you can expect of us**
As we work to develop treatments that take care of others, we work to care for our teammates’ professional and personal growth and well-being.
- Growth opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
**LOCATION:** Flexibility to work from home with few days per month working from our Cambridge or Uxbridge offices.
**APPLY NOW**
**for a career that defies imagination**
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**careers.amgen.com**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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