Job detail for Regulatory Affairs Analyst - Clinical Research

Career Category

Regulatory

Job Description

JOIN THE AMGEN MISSION TO SERVE PATIENTS

At Amgen, if you feel like you are part of something bigger, it is because you truly are. Our shared mission — to serve patients living with serious illnesses — drives everything we do.

Since 1980, we have been pioneers in the world of biotechnology in our fight against the world's most difficult diseases. With our focus on four therapeutic areas — Oncology, Inflammation, General Medicine, and Rare Diseases — we reach millions of patients each year. As a member of the Amgen team, you will help make a lasting impact on patients' lives as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, and happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities they offer, you will thrive as part of the Amgen team. Join us and transform patients' lives while transforming your career.

Mid-Level Regulatory Affairs Analyst for Clinical Research

What you will do

The professional will be responsible for the preparation, submission, and maintenance of dossiers and regulatory processes to ANVISA, ensuring compliance with local regulations, international Good Clinical Practice (ICH-GCP) guidelines, and corporate procedures.

The position will work in close collaboration with the Regulatory Submissions Manager for Clinical Research, local and global Clinical Operations, Registration, Quality, and teams, as well as external partners, contributing to obtaining and maintaining the regulatory approvals necessary for conducting clinical trials in Brazil.

Main activities:

• Prepare, compile, and submit clinical research regulatory dossiers to ANVISA, including initial DDCM and DEEC submissions, amendments, periodic reports, and study closures.
• Update and monitor regulatory timelines and support the achievement of critical clinical project milestones.
• Keep internal systems, regulatory databases, and area metrics up to date.
• Participate in local and global team meetings to align regulatory strategies and monitor studies.

Achieve

What we expect from you

We are all different, but we use our unique contributions to serve patients. The qualified professional we are looking for is a Mid-Level Analyst with the following qualifications:

Basic Qualifications:

• Degree in a health-related field, preferably Pharmacy.
• Minimum of 2 years of experience in clinical research regulatory activities within the pharmaceutical industry or CROs.
• Knowledge of regulations applicable to clinical research in Brazil and principles of Good Clinical Practice.
• Advanced English, both verbal and written.

Thrive

What you can expect from us:

While we work to develop treatments that care for others, we also care for the professional growth and personal well-being of our colleagues.

In addition to the base salary, Amgen offers competitive and comprehensive compensation packages aligned with local industry standards.

As an organization dedicated to improving the quality of life for people around the world, Amgen promotes an inclusive environment with diverse, ethical, committed, and highly qualified people who respect each other and live the Amgen values to continue advancing science in the service of patients. Together, we compete in the fight against serious diseases.

Amgen does not discriminate in its employment opportunities based on sex, race, color, age, nationality, political or religious ideas, gender, sexual orientation, gender identity, level and type of disability, ethnic origin, or any other category protected by law.