Sr. Associate, Nonclinical Regulatory Specialist

Career Category

Project Management

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Sr. Associate, Nonclinical Regulatory Specialist

What you will do

Let’s do this. Let’s change the world. In this vital role, you will partner with nonclinical scientists and functional representatives (eg, Pharmacology, Toxicology, Pharmacokinetics & Drug Metabolism), global and regional regulatory leads, and cross-functional stakeholders to enable regulatory readiness of nonclinical deliverables throughout the product lifecycle. This role offers a unique opportunity to contribute to the advancement of innovative therapies by serving as a trusted operational partner at the intersection of science, regulatory affairs, and submission management. As a member of the Research Data Management (RDM) organization, you will provide operational and regulatory support by coordinating planning, timelines, communications, and cross-functional execution to help ensure nonclinical regulatory deliverables are completed with quality, consistency, and alignment to regulatory expectations, development objectives, and Amgen quality standards.

Research Data Management (RDM) is a strategic execution function that partners with Research and Regulatory teams to enable the planning, coordination, and readiness of nonclinical regulatory deliverables across the product lifecycle. By combining nonclinical regulatory coordination, document planning, and operational execution, RDM enables nonclinical teams to deliver high-quality regulatory deliverables that support global regulatory milestones. This role serves as a trusted operational partner to nonclinical teams and regulatory stakeholders, helping translate nonclinical regulatory strategies into coordinated execution while providing visibility, alignment, and proactive support across functional stakeholders.

Responsibilities

Nonclinical Regulatory Specialist

• Partner with nonclinical scientists, functional area representatives, and regulatory stakeholders to coordinate activities supporting nonclinical regulatory planning, document development, and regulatory readiness.
• Develop, maintain, and communicate integrated timelines for nonclinical regulatory documents and deliverables, ensuring alignment with development objectives and key regulatory milestones.
• Support execution of nonclinical regulatory strategies by coordinating cross-functional activities and facilitating delivery of nonclinical regulatory packages.
• Facilitate cross-functional planning meetings, document decisions, track action items, and proactively follow up on commitments.
• Monitor progress, identify risks or potential delays, communicate issues to stakeholders, and support development of mitigation plans.
• Serve as the day-to-day operational partner for assigned product teams, fostering collaboration and alignment across scientific, regulatory, and operational functions.

Cross-Functional Collaboration & Operational Excellence

• Build strong collaborative relationships with nonclinical scientists, regulatory partners, and cross-functional stakeholders to facilitate effective communication and execution.
• Ensure activities are conducted in accordance with applicable regulatory requirements, internal quality standards, and established business processes.
• Support development and maintenance of standard operating procedures (SOPs), templates, job aids, and operational guidance documents.
• Identify opportunities to improve planning, coordination, communication, and operational efficiency across nonclinical regulatory activities.
• Participate in continuous improvement initiatives that en