Sr Mgr - Technical Product Owner Regulatory AI

BioSpace; Thousand Oaks (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Comprehensive benefits package

Discretionary annual bonus

Flexible work options

Stock-based long-term incentives

Flexible time-off plans

Job summary

A leading biopharmaceutical company is searching for a Sr Mgr - Technical Product Owner Regulatory AI to enhance their Regulatory Content Automation capabilities. The successful candidate will lead Agile product teams, ensuring compliance with regulations such as FDA guidelines while managing integrations with technologies like Veeva Vault and AWS. Candidates must have extensive experience in Information Systems, particularly in Regulatory and Document Management systems. The role offers competitive benefits and a collaborative work environment.

Qualifications

• Extensive experience in Information Systems roles, with a minimum of 2 to 12 years based on degree.
• Hands-on experience with Agile / SAFe delivery and CI/CD practices.
• Strong knowledge of regulatory processes and compliance requirements in a technology context.

Responsibilities

• Support and enhance Regulatory Content Automation capabilities.
• Lead Agile product teams in planning and delivery.
• Ensure compliance with FDA regulations and validate systems.
• Oversee validation activities and audit readiness documentation.

Skills

Agile / SAFe delivery

DevOps

CI/CD practices

Influencing stakeholders

Communication skills

Experience in life sciences

GenAI development

Cross-functional collaboration

Education

Doctorate degree in Information Systems

Masters degree in Information Systems

Bachelors degree in Information Systems

Associates degree in Information Systems

High School Diploma/GED

Tools

Veeva Vault RIM

AWS

Document management solutions

GenAI platforms

Regulatory publishing systems

Job description

Sr Mgr - Technical Product Owner Regulatory AI

Join Amgen’s mission of serving patients. Since 1980, we’ve helped pioneer the world of biotech in the fight against the world’s toughest diseases. With focus on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year.

What you will do

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

The experienced professional we seek is a senior individual contributor and delivery leader with the following qualifications.

Basic Qualifications

• Doctorate degree and 2 years of Information Systems experience
• Masters degree and 4 years of Information Systems experience
• Bachelors degree and 6 years of Information Systems experience
• Associates degree and 10 years of Information Systems experience
• High School Diploma/GED and 12 years of Information Systems experience
• Hands‑on experience with Agile / SAFe delivery, DevOps, and CI/CD practices

Preferred Qualifications

• 1‑3 years of Technical Product Manager experience for an AI/Automation product
• 58+ years of experience in Regulatory Information or Document Management process and systems or Clinical/Safety/Labeling 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.

What You Can Expect Of Us

We support your professional and personal growth through competitive benefits, collaborative culture, and work/life balance. The anticipated annual salary range for this role in the U.S. (excluding Puerto Rico) is posted; actual salary varies by skills, experience, and qualifications.

In addition to the base salary, Amgen offers a total rewards plan, including:

• A comprehensive employee benefits package with retirement and savings plan, 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.

Apply now and make a lasting impact with the Amgen team.

Apply at careers.amgen.com.

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.

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.

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.

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.