Senior Regulatory Affairs 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 enhance regulatory readiness, document planning, and team effectiveness. Contribute to a collaborative team environment through knowledge sharing, continuous learning, and support of departmental initiatives. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborative, science-minded professional with the following qualifications. Basic Qualifications Master's degree OR Bachelor's degree and 2 years of directly related experience OR Associate's degree and 6 years of directly related experience OR High school diploma / GED and 8 years of directly related experience Preferred Qualifications Experience supporting pharmaceutical research and development or nonclinical drug development programs within the biotechnology, pharmaceutical, or life sciences industry. Understanding of nonclinical drug development, regulatory requirements, and the role of nonclinical data and documentation in global regulatory submissions. Experience coordinating complex, cross-functional programs involving multiple scientific and operational stakeholders. Demonstrated project or program management skills, including timeline development, milestone tracking, risk management, and facilitation of cross-functional meetings. Demonstrated ability to build collaborative relationships and influence cross-functional teams without direct authority. Strong organizational skills with the ability to manage multiple priorities in a dynamic, fast-paced environment. Excellent written, verbal, and interpersonal communication skills with the ability to build productive relationships across scientific and business functions. Experience coordinating scientific or regulatory documents throughout the document lifecycle. Demonstrated ability to identify opportunities to improve operational processes and implement practical solutions, preferably using AI/ML applications. Experience working with document management systems, collaboration platforms, and project management tools. Experience leveraging digital technologies, collaboration platforms, automation tools, or AI-enabled solutions to improve operational effectiveness is desirable. Familiarity with Good Laboratory Practice (GLP), Good Documentation Practices (GDP), and global regulatory expectations for nonclinical documentation. Bachelor's or advanced degree in a life science discipline, regulatory affairs, business, or a related field. What you can expect of us From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Salary Range 101,675.30USD -137,560.70 USD Sponsorship Sponsorship for this role is not guaranteed. 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. Equal Opportunity Employer 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. Applicant Information In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Company Information Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit and follow us on #J-18808-Ljbffr