高级专员 - 法规事务
Senior Associate - Regulatory Affairs
### **职业类别**
监管
### **职位描述**
### 加入安进为患者服务的使命
在安进，如果你觉得你属于更大的事物，那是因为你确实如此。我们共同的使命——为患有严重疾病的患者服务——推动着我们所做的每一件事。
自1980年以来，我们在对抗世界上最难治愈的疾病中，帮助开创了生物技术的世界。我们专注于四个治疗领域——肿瘤学、炎症、普通医学和罕见病，每年惠及数百万患者。作为安进团队的一员，你将帮助对患者的生活产生持久的影响，我们通过研究、制造和提供创新药物，帮助人们活得更长、更充实、更快乐。
我们获奖的文化是协作、创新且以科学为基础的。如果你热衷于挑战以及其中的机会，你将在安进团队中茁壮成长。加入我们，改变患者的生活，同时改变你的职业生涯。
**高级专员 – 监管事务**
### **你将负责的工作**
让我们一起行动，改变世界。安进的监管事务高级专员在确保公司产品符合并保持监管标准方面发挥重要作用。他们协助准备向监管机构提交的文件，及时了解监管法规的变化，并指导公司内部各团队以确保符合相关法规。
**主要职责：**
- 协助区域监管负责人支持区域监管活动
- 与区域监管负责人合作，提供和维护IND/MA文档支持（例如年度报告、修订）
- 通过RIM创建和维护产品监管历史文件。适当归档所有监管文件和机构沟通内容
- 审阅全球监管战略计划（GRSP）的区域部分，并为运营交付物提供输入；根据全球或区域监管负责人指派，进行监管研究以支持GRSP计划内容的开发
- 积极支持监管合规，并确保向监管机构提交的文件符合要求
- 协助全球或区域监管负责人准备监管交付物的支持性文件，包括例如监管环境或监管策略和/或目标产品标签的研究
- 协调功能文件的收集
查看英文原文
### **Career Category**
Regulatory
### **Job Description**
### Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Senior Associate – Regulatory Affairs**
### **What you will do**
Let’s do this. Let’s change the world. The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable regulations.
**Key Responsibilities:**
- Assist Regional Regulatory Lead to support regional regulatory activities
- Provide and maintain IND/MA documentation support (e.g. annual reports, amendments) in collaboration with Regional Regulatory Lead
- Create and maintain product regulatory history documents through RIM. Appropriately archive all regulatory documents and agency communications
- Review regional component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; perform regulatory research to support the development of content for the GRSP plan as delegated by the Global or Regional regulatory lead
- Actively support regulatory compliance and ensure compliance of submissions to regulatory agencies
- Assist the Global or Regional Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label.
- Coordinate collection of functional documents in support of regulatory applications
- Participate in GRT and assist the Global or regional regulatory lead in meeting management (eg, agendas and minutes for GRTs) to advance regulatory knowledge of the product and processes
- Assist the global or regional regulatory lead in managing the process for responding to regulatory agency questions.
- Coordinate QC of regulatory documentation (e.g. briefing packages)
- Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
- Prepare regulatory packages and cross-reference letters to support investigator initiated studies
- Complete regulatory forms to support agency communications (E.G. FDA form 1571)
- Support process improvement initiatives, standards development, and metrics
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to GRT
- Support the development and execution of GRT goals
### **What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a go-getter with these qualifications.
**Basic Qualifications:**
Master’s degree
**Or**
Bachelor’s degree and 2 years of Regulatory Affairs experience
**Or**
Associate’s degree and 6 years of Regulatory Affairs experience
**Or**
High school diploma / GED and 8 years of Regulatory Affairs experience
**Preferred Qualifications:**
- Bachelor’s degree in Life Sciences and 2-3 years of Regulatory Affairs experience
- Experience setting up regulatory submissions
### What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
### Apply now and make a lasting impact with the Amgen team.
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
### Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
### Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided 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 accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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**Salary Range**
83,974.90USD -113,613.10 USD