Sr Mgr Regulatory Affairs

Amgen(6 months ago)

HybridFull TimeManager$144,203 - $188,635 (estimated)Regulatory Affairs

About this role

A Senior Manager — International Regulatory Lead (Gen Med/Biosims) at Amgen provides regulatory leadership and expertise for the development, registration, and lifecycle management of assigned high-impact molecules across international markets. The role focuses on aligning global and local regulatory approaches and representing regulatory perspectives within cross-functional teams to ensure adherence to regional legislation and guidance.

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Required Skills

Regulatory Strategy
Regulatory Submissions
Labeling
Compliance
Stakeholder Management
Negotiation
Communication
Regulatory Research
Mentoring
Clinical Development

Qualifications

Doctorate
Master's Degree (Scientific) + 6 years experience
Bachelor's Degree (Scientific) + 8 years experience

About Amgen

amgen.com

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

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