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Regulatory Affairs Manager at Amgen - ApplyBlast

Regulatory Affairs Manager

Amgen

4 months ago

3.6 on Glassdoor

United Kingdom

Hybrid

Full Time

Executive

0 applicants

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About this role

A Regulatory Affairs Manager at Amgen ensures the company acquires and maintains licenses to support clinical trials and commercial marketing of medicinal products. The role involves planning regulatory submissions, implementing regulatory strategies, providing guidance on regional mechanisms, and monitoring legislative changes within the European Oncology team.

Responsibilities

Plan and manage regulatory submissions for product portfolios
Implement regional regulatory strategies and processes
Provide guidance on regulatory mechanisms and label negotiations
Maintain awareness of evolving legislation and policy
Evaluate impact of regional regulations on product advancement

Skills

Qualifications

Scientific DegreeRegulatory Affairs Experience

About Amgen

amgen.com

Headquarters

Thousand Oaks, California, United States

Company Size

10001+ employees

Founded

1980

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Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.