Associate Regulatory Affairs
Associate Regulatory Affairs
Mexico - Mexico City Apply NowJoin 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 Associate
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will be responsible for:
Coordinate the main activities for the submission of the Life Cycle Management of product registration like renewals, and product variations.
To update the dossier in the Amgen´s systems for the accurate traceability of the products.
To verify that updated labeling are accurate for submission (mock-ups) and its implementation (artwork).
To hand-off the accurate source text in the respective Amgen´s system for the labeling implementation.
To be aware about the updates in the local regulations and connect with the main stakeholders.
To attend the follow-up meetings related with the life cycle management of the product in charge of with International Regulatory Lead (IRL), CMC lead supply, Regional Operation Lead (ROLs), medical, etc.
Ensure all regulatory submissions are made on time and meet local regulatory requirements. These changes can include but they are not limited to: New MAAs, renewals, labeling updates, technical changes.
To review, analysis, and respond to questions (RTQ) whenever necessary related to the submitted procedures , and requested by the Health Authority.
To review promotional and non-promotional materials.
Request and provide legal documents when needed to the regulatory procedure.
Update and keep current the applicable databases needed for the latam RA department.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek is a type of person with these qualifications.
Basic Qualifications:
Bachelor’s degree OR
Associate’s degree and 4 years of in regulatory affairs in Mexico and LATAM countries experience OR
High school diploma and 6 years of in regulatory affairs in Mexico and LATAM countries experience
Preferred Qualifications:
1-3 years of experience in regulatory affairs in Mexico and LATAM countries.
This person can coordinate meetings, follow-up the procedures and activities with the stakeholders, without close supervision. Facilitate the communication with internal and external stakeholders.
English (advance)
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
