Senior Regulatory Affairs Associate

Amgen

Regulatory Affairs Senior Associate at Amgen assisting in regulatory document creation and submission. Supporting US regulatory activities and compliance under USRL supervision.

Posted 5/19/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $83,974 - $113,613 per yearWebsite

About the role

Key responsibilities & impact

Assist US Regulatory Lead (USRL) to support US regulatory activities (e.g. development and submission of Investigational New Drug [IND] applications, Biologic License Applications [BLAs] and New Drug Applications [NDAs]; advisory committee meeting preparations)
Provide and maintain IND/BLA/NDA documentation support (e.g. annual reports, amendments) in collaboration with USRL
Create and maintain product regulatory history documents in the regulatory document management system and appropriately archive all regulatory documents and agency communications
Review US component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; perform regulatory research to support the development of content for the GRSP plan as delegated by the Global or US Regulatory Lead
Actively support regulatory compliance and ensure compliance of submissions to the US FDA
Assist the Global or US Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label
Coordinate collection of functional documents in support of regulatory applications
Participate on Global Regulatory Teams (GRT) and assist Global Regulatory Leads with GRT meeting management (eg, agendas and meeting minutes)
Assist the USRL in managing the process for responding to FDA questions
Coordinate Quality Check (QC) of regulatory documentation (e.g. briefing packages)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports)
Prepare regulatory packages and cross-reference letters to support investigator initiated studies
Complete regulatory forms to support agency communications (e.g. FDA form 1571)
Support process improvement initiatives, standards development, and metrics
Assist in template development and maintenance
Respond to specific requests from and communicate relevant issues to GRT
Support the development and execution of GRT goals

Requirements

What you’ll need

Master’s degree
Or Bachelor’s degree and 2 years of regulatory or pharmaceutical experience
Or Associate’s degree and 6 years of regulatory or pharmaceutical experience
Or High school diploma / GED and 8 years of regulatory or pharmaceutical experience

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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Applicant Tracking System Keywords

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Hard Skills & Tools

IND applicationsBLA submissionsNDA submissionsregulatory documentationregulatory complianceregulatory researchregulatory correspondenceregulatory packagesQuality Check (QC)regulatory forms

Soft Skills

communicationcollaborationorganizationalmeeting managementprocess improvementsupportive documentationproblem-solvingattention to detailtime managementteamwork