Clinical Trials Regulatory Submission Associate

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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. Join us and transform the lives of patients while transforming your career.

Clinical Trials Regulatory Submission Associate

What you will do

Let’s do this. Let’s change the world. In this vital role you will you will support the execution of clinical trial regulatory submissions and related regulatory activities in Argentina, ensuring compliance with applicable local regulations, Good Clinical Practice (GCP) requirements, and Amgen policies and procedures.

The position focuses on the preparation, review, submission, tracking, and maintenance of regulatory documentation and administrative processes throughout the clinical trial lifecycle, working under the guidance of the Local Regulatory Affairs team.

• Provide administrative and operational support to the Local Regulatory Affairs team, including preparation of regulatory forms, management of documentation, and coordination of submission-related activities.

• Prepare, review, and submit clinical trial regulatory documentation to ANMAT, CCIS, and other applicable authorities, ensuring compliance with local requirements and procedures.

• Maintain regulatory tracking tools, submission logs, databases, and study milestones, ensuring accurate records, timely follow-up, and communication of status updates to relevant stakeholders.

• Perform clinical trial registration and maintain study information in the Argentine National Registry of Health Research (RENIS), based on information provided by study teams.

• Maintain, archive, and file regulatory submissions, approvals, correspondence, and essential study documents in Amgen systems, ensuring completeness, version control, and compliance with record retention requirements.

• Coordinate clinical trial submission and study start-up activities, including document collection, follow-up on pending items, meeting scheduling, and collaboration with internal teams and external service providers.

• Support routine administrative processes related to regulatory activities, including purchase orders, vendor documentation, invoice tracking, and payment follow-up, in accordance with Amgen procedures.

• Use Amgen-approved digital and AI tools to support administrative and regulatory activities, including information organization, draft summaries, document review, identification of missing information, and maintenance of trackers, ensuring compliance with company policies and confidentiality requirements.

• Identify opportunities to simplify or automate recurring administrative processes and propose improvements to enhance team efficiency.

• Participate in regulatory and study-related meetings and execute assigned activities in compliance with local regulations, Good Clinical Practice (GCP), and Amgen Standard Operating Procedures.

• Escalate issues, risks, or gaps to leadership and support the development of mitigation plans.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. We seek a professional with these qualifications.

Basic Qualifications:

Master’s degree OR Bachelor’s degree and 3 years of Clinical Trials experience.

Preferred Qualifications:

• At least 1 year of experience in regulatory affairs and/or clinical trial start-up activities, with knowledge of Argentine clinical trial regulations (ANMAT and CCIS).

• Strong written and verbal communication skills in English, with the ability to effectively interact with internal and external stakeholders.

• Excellent organizational and time-management skills, with the ability to manage multiple priorities, track activities, meet deadlines, and maintain accurate records.

• Strong interpersonal and collaboration skills, with the ability to build effective working relationships across cross-functional, matrixed, and geographically dispersed teams.

• Ability to work independently while demonstrating initiative, accountability, and sound judgment in assigned responsibilities.

• High attention to detail and commitment to accuracy, quality, and compliance in regulatory documentation and processes.

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 and make a lasting impact with the Amgen team.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

.Originally posted on Himalayas