Senior Regulatory Affairs Associate - US/Global

BioSpace; Washington (District of Columbia); On-site; USD 110,000 - 140,000; Full time

Job summary

Amgen in Washington, DC, seeks a Senior Associate - Regulatory Affairs to support US Regulatory Leads and the Global Regulatory Team. You will coordinate US regulatory submissions, manage documentation delivery and archiving, and assist in managing GRT interactions.

The role requires strong communication, collaboration, and the ability to navigate regulatory processes across multiple teams. Competitive benefits and a dynamic, science-driven environment are offered.

Qualifications

• Masters degree
• Or Bachelor’s degree and 2 years of Regulatory Affairs experience
• Or Associates degree and 6 years of Regulatory Affairs experience
• Or High school diploma / GED and 8 years of Regulatory Affairs experience

Responsibilities

• Coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements.
• Manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions
• Assist the Global Regulatory Lead to manage GRT interactions
• Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
• Provide and maintain CTA/MA documentation support in collaboration with US Regulatory Lead
• Create and maintain product regulatory information and history documents through Amgen systems
• Archive regulatory documents and agency communications
• Collaborate with CROs / partners to support site initiation
• Complete regulatory forms to support agency communications
• Participate in GRT to support execution of regulatory strategy

Skills

Strong communication skills

Scientific/clinical information

Collaboration

Cultural awareness

Planning and organizing

Prioritize multiple activities

Ambiguity tolerance

Influence others

Education

Masters degree

Job description

Amgen in Washington, DC, seeks a Senior Associate - Regulatory Affairs to support US Regulatory Leads and the Global Regulatory Team. You will coordinate US regulatory submissions, manage documentation delivery and archiving, and assist in managing GRT interactions.

The role requires strong communication, collaboration, and the ability to navigate regulatory processes across multiple teams. Competitive benefits and a dynamic, science-driven environment are offered.