位于北京市, c22的 20 个优质software dev engineer intern, 2026 beijing职位（正在招聘！）

Regulatory Affairs Manager
Amgen —北京市
5 小时
Account Executive
DEKRA —北京市
- 全职
Direct Retail Specialist
Cathay Pacific —北京市
Advisory Industrial Designer/工业设计师
Lenovo —北京市
Master Planning Professional
Lenovo —北京市
8天
History Teacher
Elevate —北京市
- 年薪312,000-384,000元
快速申请
Senior Specialist, AI Training
Lenovo —北京市
IT Financial BP
Lenovo —北京市
Global Program Manager
Lenovo —北京市
8天
Strategic Program Manager
Lenovo —北京市
19 小时
HRIS Analyst (Workday Consultant)
Lenovo —北京市
AI Engineering Sr. Project Manager
Lenovo —北京市
- 全职
OD Consultant
Lenovo —北京市
3天
Agent Delivery Lead
Lenovo —北京市
10天
Sr. Manager, Quality Engineering/AI软件测试高级经理
Lenovo —北京市
10天
保险行业AI产品经理
Lenovo —北京市
- 全职
DT Financial BP
Lenovo —北京市
English Language ELA Teacher
Elevate —北京市
- 年薪372,000-480,000元
快速申请
English Teacher
Elevate —北京市
- 年薪450,000-480,000元
快速申请
Visuals Product Manager
Lenovo —北京市
2天

我想收到关于北京市, c22 的 software dev engineer intern, 2026 beijing 的最新职位提醒

一旦登录您的账户，即表明您同意 SimplyHired 的服务条款和我们的Cookie 协议及隐私政策。

Regulatory Affairs Manager

Amgen -
北京市

立即申请

职位详情

5 小时前

完整职位描述

China - Beijing

JOB ID: R-247404 LOCATION: China - Beijing WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Jun. 11, 2026 CATEGORY: Regulatory

Job Description

Applying, obtaining and maintaining regulatory approvals for products within Amgen’s portfolio, including CTN, MAA, renewal, variations of product’s life cycle management.
Ensure that regulatory submissions are made on time and meet Amgen corporate standards and local regulatory requirements.
Developing (with manager’s guidance) and implementing product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
Undertake interactions and negotiations with Regulatory Authorities, to optimize regulatory approvals.
Participate in the local implementation of key Regulatory projects.
Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen pipeline.
Provide regulatory support for Therapeutic Areas/Scientific Affairs activities.
Where applicable, oversee external vendor/contractor relationships.
Feedback on any Regulatory Intelligence to International Regulatory Affairs

Knowledge and Skills

Regulatory expertise in national, MRP, centralized and biotechnology products, medical devices
Interactions with regulatory authorities
Working with policies, procedures and SOPs
Knowledge of national legislation and regulations relating to medicinal products
Understanding of the registration procedures in Europe and US for MAA, variations, extensions and renewals
Understanding of drug development
Experience managing regulatory processes
Scientific / Technical Excellence
Communication Skills: Oral and Written
Team Work
Negotiation Skills
Ability to anticipate and prevent potential issues

Basic Qualifications

Doctorate degree

Master’s degree and 3 years of directly related experience

Bachelor’s degree and 5 years of directly related experience

Associate’s degree and 10 years of directly related experience

Preferred Qualifications:

Experience in MNCs,
Experience in biologics
Experience in medical devices registration field
Multi-lingual

立即申请

完善您的搜索

在北京市, c22的software dev engineer intern, 2026 beijing个职位

Regulatory Affairs Manager

Account Executive

Direct Retail Specialist

Advisory Industrial Designer/工业设计师

Master Planning Professional

History Teacher

Senior Specialist, AI Training

IT Financial BP

Global Program Manager

Strategic Program Manager

HRIS Analyst (Workday Consultant)

AI Engineering Sr. Project Manager

OD Consultant

Agent Delivery Lead

Sr. Manager, Quality Engineering/AI软件测试高级经理

保险行业AI产品经理

DT Financial BP

English Language ELA Teacher

English Teacher

Visuals Product Manager

我想收到关于北京市, c22 的 software dev engineer intern, 2026 beijing 的最新职位提醒

Related Searches

求职者工具

雇主工具

浏览

保持联系

完善您的搜索

在北京市, c22的software dev engineer intern, 2026 beijing个职位

我想收到关于 北京市, c22 的 software dev engineer intern, 2026 beijing 的最新职位提醒

Related Searches

我想收到关于北京市, c22 的 software dev engineer intern, 2026 beijing 的最新职位提醒