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Regulatory Affairs Manager

Amgen -
北京市

立即申请

职位详情

9 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

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

Regulatory Affairs Manager

Visuals Product Manager

Early Childhood Education Teacher

Visuals Regional Business Operation Manager

Sr. Project Management Specialist

SITE INDUSTRIAL MANAGER

Assistant Manager FRS Ops North

Sr. Financial P&A specialist (DWS)

Solution Product Marketing Manager

Sr PBM Specialist

Manager Visual Excellence, North

Sr. Specialist, Product Management

Social Studies Teacher

Expense Governance Manager (费控治理专家)

ELA English Teacher

Mgr Financial P&A - ISG PRC

Vocal Music Teacher

Sales Manager

English Literature Teacher

Sr. Key Parts Manager

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

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