Sr Mgr - Technical Product Owner Regulatory AI

Amgen • Thousand Oaks, CA

1d

About The Position

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 Mgr - Technical Product Owner Regulatory AI What you will do Let’s do this. Let’s change the world. In this vital role you will support and advance the Regulatory Content Automation capability ecosystem Process & Platform Leadership Serve as the Technology Process lead for regulatory content automation solutions, including structured content authoring, publishing, submission, and downstream integrations. Define, document, and maintain end-to-end regulatory processes, ensuring consistency, scalability, and alignment with global regulatory standards. Lead post-MVP stabilization efforts, continuous improvement initiatives, and future roadmap development aligned with regulatory transformation goals. Act as IT Application Owner for designated platforms, including lifecycle management, system decommissioning, and integration oversight. Delivery & Agile Execution Drive planning, execution, and delivery across Agile / SAFe product teams, serving as a key contributor in PI planning, backlog prioritization, and dependency management. Translate regulatory business needs into clear business and technical requirements, partnering with engineering and architecture teams to deliver fit-for-purpose solutions. Apply and reuse global technology capabilities and standards to deliver differentiated, compliant platforms. Compliance, Validation & Audit Readiness Lead GxP and computer system validation activities, including implementation of Risk-Based Validation (RBV) strategies. Ensure ongoing compliance with FDA 21 CFR Part 11, GxP, and Amgen SOPs. Support audit and inspection readiness through ownership of validation documentation, system controls, and traceability artifacts. Technology Enablement & Integration Lead technical discussions and integrations across platforms such as Veeva Vault RIM, AWS (e.g., S3), structured content tools, GenAI-enabled capabilities, and document management solutions. Partner with data, UX, and architecture teams to ensure solution quality, performance, and extensibility. Evaluate vendors and emerging technologies through proof-of-concepts and pilots, ensuring alignment with enterprise standards and user experience goals. People & Stakeholder Leadership Mentor and guide junior business analysts and delivery team members, promoting ownership, continuous learning, and cross-functional collaboration. Engage business stakeholders to set expectations, manage priorities, and ensure transparent communication. Support diversity, inclusion, and team engagement initiatives within the organization. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a a senior individual contributor and delivery leader with these qualifications.

Requirements

• Doctorate degree and 2 years of Information Systems experience OR Master’s degree and 4 years of Information Systems experience OR Bachelor’s degree and 6 years of Information Systems experience OR Associate’s degree and 10 years of Information Systems experience OR High School Diploma/GED and 12 years of Information Systems experience
• Hands-on experience with Agile / SAFe delivery, DevOps, and CI/CD practices

Nice To Haves

• 1-3 years of Technical Product Manager experience for an AI/Automation product
• 5–8+ years of experience in Regulatory Information or Document Management process and systems or Clinical/Safety/Labelling Document Management processes and systems.
• 5-8+ years of experience in managing custom software development products.
• Strong experience with computer system validation, GxP, and FDA 21 CFR Part 11.
• Working knowledge of Veeva Vault RIM and regulatory publishing/submission platforms and/or Safety systems (Argus) or Clinical systems (CTMS).
• Experience in life sciences, healthcare, or similarly regulated industries.
• Hands-on experience with Agile / SAFe delivery, DevOps, and CI/CD practices.
• Familiarity with AWS cloud technologies, data integrations, and analytics.
• Strong ability to influence stakeholders and work effectively with senior leaders.
• Excellent written and verbal communication skills.
• High learning agility and passion for innovation and continuous improvement
• Strong experience with GenAI development including familiarity with RAG, Prompt Engineering, LLM fine-tuning, and Agentic Architecture.
• Strong experience in developing multi-year product roadmaps and managing a product through every aspect of the software development life cycle.

Responsibilities

• Serve as the Technology Process lead for regulatory content automation solutions, including structured content authoring, publishing, submission, and downstream integrations.
• Define, document, and maintain end-to-end regulatory processes, ensuring consistency, scalability, and alignment with global regulatory standards.
• Lead post-MVP stabilization efforts, continuous improvement initiatives, and future roadmap development aligned with regulatory transformation goals.
• Act as IT Application Owner for designated platforms, including lifecycle management, system decommissioning, and integration oversight.
• Drive planning, execution, and delivery across Agile / SAFe product teams, serving as a key contributor in PI planning, backlog prioritization, and dependency management.
• Translate regulatory business needs into clear business and technical requirements, partnering with engineering and architecture teams to deliver fit-for-purpose solutions.
• Apply and reuse global technology capabilities and standards to deliver differentiated, compliant platforms.
• Lead GxP and computer system validation activities, including implementation of Risk-Based Validation (RBV) strategies.
• Ensure ongoing compliance with FDA 21 CFR Part 11, GxP, and Amgen SOPs.
• Support audit and inspection readiness through ownership of validation documentation, system controls, and traceability artifacts.
• Lead technical discussions and integrations across platforms such as Veeva Vault RIM, AWS (e.g., S3), structured content tools, GenAI-enabled capabilities, and document management solutions.
• Partner with data, UX, and architecture teams to ensure solution quality, performance, and extensibility.
• Evaluate vendors and emerging technologies through proof-of-concepts and pilots, ensuring alignment with enterprise standards and user experience goals.
• Mentor and guide junior business analysts and delivery team members, promoting ownership, continuous learning, and cross-functional collaboration.
• Engage business stakeholders to set expectations, manage priorities, and ensure transparent communication.
• Support diversity, inclusion, and team engagement initiatives within the organization.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED