02 sep
|
Amgen
|
Ciudad de México
02 sep
Amgen
Ciudad de México
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 the lives of patients 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 lay within them, you’ll thrive as part of the Amgen team. We have proudly achieved certifications as Great Place to Work and Equidad MX. Join us and transform the lives of patients while transforming your career.
Regulatory Affairs Manager (CDMX)
The Local Regulatory Representative (LRR), Manager Mexico, is accountable for leading and executing local regulatory strategies that enable timely patient access and lifecycle management of Amgen products in Mexico.
The role leads the planning, submission, tracking, and approval of new marketing authorizations, post-approval changes, renewals, extensions, labelling updates, and other regulatory activities, in compliance with Mexican regulations, COFEPRIS requirements, and Amgen policies and standards.
The LRR serves as a key regulatory advisor and primary local interface with COFEPRIS and relevant stakeholders, proactively identifying regulatory risks, defining mitigation plans, and partnering with General, Regional, and cross-functional teams to support business priorities and protect product supply and compliance.
What you will do
Let’s do this. Let’s change the world. In this vital role you w
📌 Regulatory Affairs Manager (Ciudad de México)
🏢 Amgen
📍 Ciudad de México