Regulatory Professional Role at Amgen USA
Amgen is hiring a United States Regulatory Professional – Obesity and Related Conditions for a fully remote position in the USA. This exciting life sciences job offers professionals an opportunity to work closely with FDA submissions and regulatory lifecycle management while contributing to therapies that impact millions of patients worldwide. If you are looking for jobs in USA within a leading biotech company, this role at Amgen is a strong career move.
Job Details:
- Job Role: United States Regulatory Professional (USRP)
- Therapeutic Area: Obesity and Related Conditions
- Job ID: R-234530
- Location: United States – Remote
- Work Type: Full-time
- Category: Regulatory Affairs
- Salary Range: USD 88,347 – 110,633 per year
About the Company:
Amgen is one of the world’s leading biotechnology companies, driven by a mission to serve patients through science and innovation. With products reaching over 10 million patients globally, Amgen is known for its collaborative culture, ethical values, and strong commitment to advancing treatments for serious diseases. Working at Amgen means being part of a global team dedicated to improving lives. Explore more life sciences job offers in USA.
Educational Requirements:
- Master’s degree in biology, life sciences, health sciences, or regulatory science
OR - Bachelor’s degree in a science discipline with 2 years of related experience
OR - Associate degree in a science discipline with 6 years of related experience
OR - High school diploma/GED with 8 years of directly related experience
Key Responsibilities of Regulatory Professional Role:
- Coordinate and execute U.S. regulatory submissions in line with FDA and Amgen standards
- Manage submission timelines and ensure on-time delivery of regulatory documents
- Maintain regulatory records, documentation, and electronic archiving
- Support U.S. labeling updates and review source texts
- Assist in FDA interactions and regulatory meetings
- Coordinate responses to health authority queries
- Track and communicate U.S. regulatory policy updates
- Support cross-functional regulatory governance activities
Skills Required for Regulatory Professional Role:
- Regulatory affairs experience in biotech or pharmaceutical industry
- Strong written and verbal communication skills
- Excellent organizational and time-management abilities
- High attention to detail and document quality
- Ability to manage multiple stakeholders and deadlines
- Familiarity with document management systems
- Understanding of U.S. FDA regulatory requirements
Benefits of the Regulatory Professional Role:
- Competitive salary package
- Comprehensive medical, dental, and vision insurance
- Retirement and savings plans with company contributions
- Annual bonus and stock-based incentives
- Flexible remote work model
- Award-winning paid time-off policies
- Career growth and professional development opportunities
