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. Join us and trans

form 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. This role is responsible for the overall submission strategy definition, execution and management of all regulatory activities for clinical trial projects and programs, according to local regulatory regulations and Amgen’s policy. In Brazil, this position is directly accountable for clinical trial application preparation and submission to ANVISA. In other countries (Chile, Peru, Türkiye, Israel, Saudi Arabia and United Arab Emirates), is accountable for the oversight of activities executed by outsourced functional service providers (FSP), being the communication point of contact, according to Amgen FSP hub model.

This position works directly with Functional Service Providers for Regulatory and Ethics Committee Services, Clinical Project Management, Global Study & Site Operations, International Regulatory Team, CMC Global Product Leads and Global Safety.

Key responsibilities:

• Lead the end-to-end management of Clinical Trial Applications (CTAs) and regulatory submissions in Brazil for new and ongoing clinical development projects and programs, ensuring full compliance with local regulatory requirements. This includes  preparing initial submissions to ANVISA (DDCM/DEEC), clinical protocol amendments, CMC/quality amendments, authoring local documents and application forms, periodic study reporting, and all regulatory activities through study closure. Post-trial access and Expanded Access programs submission and maintenance.
• In other countries, the core activity is end-to-end vendor oversight for regulatory submissions, be the main point of contact, including vendor invoice review and approval.
• Develop and maintain comprehensive regulatory submission and approval strategies for each study, in collaboration with internal stakeholders, external service providers, and cross-functional teams, ensuring alignment with project objectives and timelines.
• Conduct regulatory impact and substantiality assessments in accordance with applicable local regulations, guidance documents, and agency requirements to determine submission pathways and regulatory obligations.
• Ensure high standards of operational excellence by monitoring team performance, submission quality, compliance with SOPs, adherence to regulatory requirements, and achievement of project milestones and timelines.
• Provide regular updates on regulatory status, risks, timelines, and key milestones to internal teams, project leaders, and external partners, ensuring transparency and effective decision-making.
• Represent Regulatory Affairs in cross-functional project meetings, providing strategic guidance on submission pathways, regulatory requirements, approval timelines, and potential regulatory risks.
• Partner closely with internal stakeholders to interpret, establish, and communicate regulatory requirements, ensuring consistent implementation across studies and projects.
• Maintain and continuously update clinical trial regulatory intelligence databases, submission trackers, regulatory intelligence tools, and study-specific checklists to ensure accuracy and compliance.
• Coordinate and support  interactions and meetings with regulatory authorities, involving both local and global teams when required, to facilitate successful regulatory outcomes.
• Provide guidance, direction, and work instructions to team members regarding regulatory submission preparation, timeline planning, issue resolution, and compliance-related activities.
• Serve as the primary regulatory liaison throughout the study lifecycle, facilitating effective communication and collaboration among regional and local study teams, including Local Study Operations Managers, Country Heads, Regulatory Affairs colleagues, vendors, contract teams, and other key stakeholders.
• Identify regulatory risks, compliance gaps, and operational challenges, escalating critical issues to leadership as appropriate and developing effective mitigation plans to maintain inspection readiness and project continuity.
• Proactively anticipate and resolve regulatory start-up challenges, developing innovative and compliant solutions to support study activation and execution within agreed timelines.
• Drive continuous improvement initiatives by identifying opportunities to enhance regulatory processes, increase operational efficiency, strengthen compliance, and implement best practices across the Regulatory Affairs function.
• Ensure all regulatory activities are conducted in accordance with applicable local regulations, international guidelines, company policies, quality standards, and ethical requirements, maintaining a state of continuous inspection readiness.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The candidate we are seeking is a financial professional with these qualifications.

Basic Qualifications:

• Bachelor’s in pharmacy or equivalent in a health-related field
• 6-7 years of clinical trials experience in Brazil, with at least 5 years of regulatory submissions / study start-up with strong technical knowledge for preparing Clinical Trials applications to ANVISA– DDCM, DEEC and maintenance activities.
• Desirable regional or global regulatory /start-up experience
• Excellent written and verbal communication skills in English
• Desirable written and verbal communication skills in Spanish

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.

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