Clinical Trials Regulatory Submission Manager (Argentina)

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. Join us and transform the lives of patients while transforming your career.

Clinical Trials Regulatory Submission Manager

What you will do

Let’s do this. Let’s change the world. In this vital role you will:

• Efficiently end-to-end manages Clinical Trials Regulatory submission in Argentina for new and ongoing project(s) or programs, including and not limited to initial applications to ANMAT and CCIS, clinical protocol amendments, ICF amendments, quality (CMC) amendments, study periodic reporting, until the project is officially closed.
• Develops, with the input of importer of record, study specific import licenses extensions and approvals and keeps it updated.
• Monitors team efficiency, quality and adherence to project timelines, SOPs and local regulations.
• Attends to regulatory inspections and corporate audits, representing the RA function.
• Communicates overall regulatory status to internal teams and service providers.
• Attends to project meetings with cross functional department leads to provide strategy, timelines and requirements for regulatory submissions and approvals.
• Works with internal team members to establish and clarify regulatory requirements
• Responsible for clinical trial regulatory regulatory intelligence, including regular updates to databases.
• Responsible for local public registry in Argentina (ReNIS database) with input of Local Trial Managers.
• Coordinate with local and global team CTA pre-submission meetings with Agency, if needed.
• Where applicable, provides work instructions to team members in preparation of regulatory submissions, timeline estimations, issues resolution, etc.
• Facilitates communication with the regional or local study team (e.g. Start-up Associates, Project Managers, Regulatory Affairs, Vendors, and Contracts Department) during the total duration of study, closely monitoring to ensure regulatory milestones are met.
• Escalates issues to leadership, including plans for addressing/mitigating risks/gaps.
• Develops proactive solutions to regulatory start-up issues and challenges.

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:

• Doctorate degree OR
• Master’s degree in Pharmacy or equivalent in a health-related field & 2 years of regulatory submissions / study start-up experience in big pharmaceutical company OR
• Bachelor’s degree in Pharmacy or equivalent in a health-related field & 4 years of experience of regulatory submissions / study start-up experience in big pharmaceutical company OR
• Associate’s degree in Pharmacy or equivalent in a health-related field and 8 years of experience regulatory submissions / study start-up experience in big pharmaceutical company OR
• High school diploma / GED and 10 years of experience regulatory submissions / study start-up experience in big pharmaceutical company a big pharmaceutical company.
• English – Business proficient

Preferred Qualifications:

• Strong technical knowledge and 3-4 years of experience in executing Clinical Trial Applications in Argentina (ANMAT, CCIS)
• Experience in preparing, attending and responding to GCP Inspection Acts issued by ANMAT.
• Experience and/or technical knowledge in other Health Authorities inspections (FDA, EMA, etc)
• Ability to conceptualize, develop and lead timelines, including its updates;
• Ability to delegate and make decisions, including risk-based ones;
• Ability to prioritize multiple projects and priorities;
• Ability to develop and maintain productive relationships with coworkers, managers and service providers.
• Ability to work independently and asynchronously with different time zones within a matrixial project team environment is essential.

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 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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.