US Regulatory Lead

Amgen

. Plan and execute regulatory strategies for assigned Amgen products in the United States .

Posted 9/25/2026full-timeRemote • United StatesSenior💰 $112,744 - $152,536 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in US Regulatory Strategies, including regulatory submissions, compliance, and product labeling. Possesses strong leadership skills and the ability to collaborate effectively with cross-functional teams and regulatory agencies.

Highest-signal resume keywords

US Regulatory ExperienceRegulatory Submissions ManagementLeadership ExperienceKnowledge of Regulatory PrinciplesDrug Development Understanding

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsProduct LabelingRegulatory ComplianceRegulatory ResearchExpedited Regulatory DesignationsPediatric PlansOrphan Drug DesignationsAgency InteractionsMarketing Authorization FilingsLifecycle Maintenance Filings

Soft Skills

Teamwork AbilityOral Communication SkillsWritten Communication SkillsNegotiation SkillsConflict Resolution

Industry Keywords

FDAUS LegislationMedicinal ProductsRegulatory EnvironmentSOPsCultural AwarenessTrade AssociationsRegulatory IntelligenceClinical Study PlanningProcess Improvement

About the role

Key responsibilities & impact

Plan and execute regulatory strategies for assigned Amgen products in the United States
Align local regulatory requirements with Amgen corporate standards
Plan and manage regulatory submissions in compliance with corporate and local requirements
Provide guidance on mechanisms to optimize product development and regulatory approvals
Develop and maintain local product labels
Ensure and support regulatory product compliance, including IMR, PMCs, pediatric plans, and agency commitments
Act as point of contact with regulatory agencies and participate in agency interactions
Support global regulatory strategies, strategic plans, and labeling documents
Contribute to filing plans and execute marketing authorization and lifecycle maintenance filings
Create, review, and approve country labeling source text and own country artwork
Collaborate with Regional and Global Study Operations teams on clinical study planning and execution
Review and approve promotional and non-promotional materials
Monitor legislation, trade associations, and the external regulatory environment
Manage urgent safety communications, DHPCs, and DIL submissions
Advise global teams on local regulatory implications
Provide regulatory expertise on expedited studies, Orphan Drug Designations, expedited regulatory designations, compassionate use, and pediatric plans
Exchange regulatory intelligence with regulatory and cross-functional teams
Partner with International and Global Regulatory Leads
Support process improvement projects and initiatives
Oversee external vendor and contractor relationships where applicable
Conduct regulatory research
Mentor junior Local Regulatory Representatives

Requirements

What you’ll need

Doctorate degree OR Master’s degree and 3 years of US Regulatory experience OR Bachelor’s degree and 5 years of US Regulatory experience OR Associate’s degree and 10 years of US Regulatory experience OR High school diploma / GED and 12 years US Regulatory experience
Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Understanding of drug development
Knowledge of Regulatory principles
Regulatory submissions experience and experience interacting with regulatory agencies (FDA)
Working knowledge of U.S. legislation/regulations relating to medicinal products and applicable regulatory principles
Comprehensive understanding of regulatory activities and their impact on other projects and/or processes
Knowledge and experience in the US regulatory environment relevant for product area and development stage
Strong teamwork ability
Good oral and written communication skills
Good negotiation and influencing skills
Ability to understand and communicate scientific/clinical information
Ability to resolve conflicts and develop a beneficial course of action
Experience working with policies, procedures, and SOPs
Cultural awareness and sensitivity across regional, country, and international borders

Benefits

Comp & perks

A comprehensive employee benefits package
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
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 support