Global Regulatory Affairs Director - Inflammation and Rare Disease

Location: Corporate Headquarters, Thousand Oaks, California, United States; Conditions: Washington, D.C., United States

Company

Amgen is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Develop and execute global regulatory product strategies for inflammation and rare disease therapies.
• Lead Global Regulatory Teams and represent Regulatory Affairs on product and commercialization governance teams.
• Create regulatory strategic plans and registration strategies supporting development, approval, labeling, and lifecycle maintenance.
• Lead global regulatory filings, including clinical trial applications, marketing applications, label extensions, and CMC changes.
• Guide core data sheet development, evidence-based product communications, and regulatory risk assessment.
• Lead regulatory agency communications, attend key agency meetings, and represent Regulatory Affairs on external partnership teams.

Requirements

• Doctorate degree and 4 years of regulatory experience in biotechnology or science; or a master’s degree and 7 years of experience; or a bachelor’s degree and 9 years of experience.
• Experience leading teams and communicating scientific and clinical information.
• Ability to anticipate strategic issues, mitigate uncertainty, resolve conflicts, and make complex decisions.
• Strong planning, organization, prioritization, negotiation, and problem-solving skills.
• Cultural awareness and sensitivity to achieve global results.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Award-winning paid time-off plans and career development opportunities.
• Flexible work models where applicable; sponsorship is not guaranteed.

Hiring process

• Applications are accepted until a suitable candidate is selected; there is no fixed application deadline.
• Reasonable accommodations are available for candidates participating in the application or interview process.