Regulatory Affairs Manager (Bogotá)

Regulatory Affairs Manager (Bogotá)

03 oct
|
Amgen
|
Bogotá

03 oct

Amgen

Bogotá

Career Category
Regulatory
Job Description
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on patients’ lives as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Regulatory Affairs Manager (Bogotá)

The Regulatory Affairs Manager for Colombia,



serving as the Local Regulatory Representative (LRR), is accountable for leading and executing local regulatory strategies that enable timely patient access and effective lifecycle management of Amgen products in Colombia.

The role leads the planning, preparation, submission, tracking, and approval of new sanitary registrations and marketing authorizations, post-approval modifications, renewals or other maintenance activities where applicable, indication extensions, labeling updates, and related regulatory activities, in compliance with Colombian regulations, INVIMA requirements, and Amgen policies and standards.

The LRR serves as a key regulatory advisor and the primary local interface with INVIMA and other relevant Colombian authorities and stakeholders. The role proactively identifies regulatory risks, defines mitigation plans, and partners with Integral, Regional, and cross-functional teams to support business priorities, main

📌 Regulatory Affairs Manager (Bogotá)
🏢 Amgen
📍 Bogotá

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