Senior Associate – Regulatory Affairs

Amgen

. Assist the Regional Regulatory Lead with regional regulatory activities .

Posted 10/1/2026full-timeRemote • United StatesSenior💰 $83,975 - $113,613 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs, including regulatory submissions, compliance, and documentation management. Proficient in preparing regulatory packages and maintaining regulatory history documents while supporting agency communications and strategic planning.

Highest-signal resume keywords

Regulatory SubmissionsRegulatory ComplianceRegulatory DocumentationRegulatory Affairs ExperienceRegulatory Research

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

IND DocumentationMA DocumentationRegulatory History ManagementRegulatory CorrespondenceRegulatory Package PreparationFDA Form 1571 CompletionQuality Control of Regulatory DocumentationRegulatory Landscape ResearchAnnual Report PreparationSubmission Compliance

Soft Skills

CommunicationCollaborationMeeting Management

Tools & Technologies

RIM

Industry Keywords

Regulatory AffairsLife SciencesGRT ActivitiesAgency CommunicationsProcess Improvement

About the role

Key responsibilities & impact

Assist the Regional Regulatory Lead with regional regulatory activities
Provide and maintain IND/MA documentation support, including annual reports and amendments
Create and maintain product regulatory history documents through RIM and archive regulatory documents and agency communications
Review regional components of the Global Regulatory Strategic Plan and provide input to operational deliverables
Conduct regulatory research supporting regulatory strategy and target product label development
Support regulatory compliance and submission compliance
Prepare supportive documentation for regulatory deliverables, including regulatory landscapes and research
Coordinate collection of functional documents for regulatory applications
Participate in GRT activities and assist with meeting management, agendas, and minutes
Assist with responses to regulatory agency questions
Coordinate quality control of regulatory documentation
Author routine regulatory correspondence, including annual reports and investigator packages
Prepare regulatory packages and cross-reference letters for investigator-initiated studies
Complete regulatory forms supporting agency communications, including FDA Form 1571
Support process improvement initiatives, standards development, metrics, and template maintenance
Respond to GRT requests and communicate relevant issues
Support development and execution of GRT goals

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
Preferred: Bachelor’s degree in Life Sciences and 2–3 years of Regulatory Affairs experience
Experience setting up regulatory submissions
Ability to support regulatory activities, documentation, submissions, compliance, and agency communications
Ability to work in the United States (excluding Puerto Rico); sponsorship is not guaranteed

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, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Career development opportunities
Work/life balance
Sponsorship for this role is not guaranteed