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Regulatory Affairs Manager

Amgen -
北京市

立即申请

职位详情

12 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

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在北京的software dev engineer intern, 2026 beijing个职位

Regulatory Affairs Manager

DT Financial BP

SITE INDUSTRIAL MANAGER

ELA English Teacher

Solution Product Marketing Manager

Sr. Specialist, Product Management

Geography Teacher

Assistant Manager FRS Ops North

Business Studies Teacher

Sr. Financial P&A specialist (DWS)

Finance Controller - Group R&D Finance BP

Early Childhood Education Teacher

高级产品经理(智能体解决方案方向)

Sales Manager

Senior Manager, Omni Channel CBL

English Literature Teacher

Social Studies Teacher

Vocal Music Teacher

Mgr Financial P&A - ISG PRC

Sr. Key Parts Manager

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