European Regulatory Affairs Lead at Amgen

Language

Compensation

€68,000 – €92,000/yr

Setup: Remote, Hybrid
Location: Cambridge, England · London, England · +1
Type: Full-time
Level: not_specified

Description

Amgen is seeking an experienced European Regulatory Affairs Lead to join their Global Regulatory Affairs function in Europe. The role involves ensuring regulatory licenses for clinical development and commercialization of medicinal products, managing regulatory submissions, implementing regulatory strategies, and leading interactions with Health Authorities. This position contributes to shaping regulatory strategy and incorporating regional requirements into global plans.

Required Skills

Regulatory Strategy
Regulatory Submissions
Drug Life Cycle
Registration Procedures
Team Leadership
Problem Solving
Scientific Communication
Stakeholder Engagement

Additional Information

Required Previous Experiences: Extensive experience in regional regulatory environment
Proven track record of developing and executing regional regulatory strategy
Preferred Qualifications: In-depth understanding of the drug life cycle and development process from a regulatory perspective
In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
Ability to lead teams and work collaboratively in a dynamic environment
Proactive approach to problem solving
Ability to understand and communicate scientific/clinical information
Ability to anticipate regulatory agency expectations
Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development

About Amgen

Amgen

life-saving medicinesThousand Oaks, California

Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines, helping make people’s lives easier, fuller and longer.