Senior Associate – Regulatory Affairs

Amgen

Senior Associate in Regulatory Affairs at Amgen, assisting with US regulatory submissions and supporting global regulatory strategy. Engaging in regulatory compliance and documentation for critical therapeutic areas.

Posted 6/9/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $83,974 - $113,613 per yearWebsite

About the role

Key responsibilities & impact

Assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization
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
Support local regulatory activities (e.g. IND submissions and agency meetings)
Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) 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 CRO’s / partners to support site initiation
Complete regulatory forms to support agency communications
Participate in GRT to support execution of regulatory strategy
Coordinate QC of regulatory documentation (e.g. briefing materials)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Assist in template development and maintenance
Respond to specific requests from and communicate relevant issues to GRT
Actively support regulatory compliance.

Requirements

What you’ll need

Master’s degree
Or Bachelor’s degree and 2 years of Regulatory Affairs experience
Or Associate’s degree and 6 years of Regulatory Affairs experience
Or High school diploma / GED and 8 years of Regulatory Affairs experience
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to collaborate with team members to tackle problems and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Able to prioritize and balance multiple activities
Ability to deal with ambiguity
Ability to influence others.

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
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.

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Hard Skills & Tools

regulatory submissionsdocumentation preparationelectronic archivingCTA documentationMA documentationQC of regulatory documentationregulatory correspondencetemplate developmentregulatory compliance

Soft Skills

strong communication skillscollaborationcultural awarenessplanning and organizingprioritizationdealing with ambiguityinfluencing others

Certifications

Master’s degreeBachelor’s degreeAssociate’s degreeHigh school diploma / GED