US Regulatory Lead — Strategy & Global Compliance

Amgen; Thousand Oaks (CA); On-site; USD 113,000 - 153,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models

Job summary

Amgen is seeking a US Regulatory Lead to provide country regulatory expertise and execution for development, registration, and lifecycle management of Amgen molecules in the United States. The role entails planning regulatory strategies, leading submissions, and acting as the main liaison with regulatory agencies, while guiding a local cross-functional team.

The candidate will collaborate with Global and Regional teams, ensure compliance with corporate standards, and contribute to regulatory

Qualifications

• Doctorate, Master’s, or equivalent regulatory degree as required.
• Experience leading US regulatory teams and strategies.
• Strong knowledge of FDA processes and US regulatory landscape.
• Ability to manage complex regulatory submissions and timelines.

Responsibilities

• Lead local regulatory strategies for assigned products.
• Plan and manage local regulatory submissions in compliance with local rules.
• Interact with regulatory agencies and provide input into global regulatory plans.
• Mentor junior regulatory staff and advise cross-functional teams.
• Monitor regulatory environment and advise on implications for development plans.

Skills

Leadership experience

Regulatory knowledge

Strategic thinking

Communication skills

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Amgen is seeking a US Regulatory Lead to provide country regulatory expertise and execution for development, registration, and lifecycle management of Amgen molecules in the United States. The role entails planning regulatory strategies, leading submissions, and acting as the main liaison with regulatory agencies, while guiding a local cross-functional team.

The candidate will collaborate with Global and Regional teams, ensure compliance with corporate standards, and contribute to regulatory