Manager – United States Regulatory Strategy, General Medicine

Amgen

Manager, United States Regulatory Lead focusing on regulatory strategy in General Medicine for Amgen. Delivering U.S.

Posted 7/16/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $112,744 - $152,536 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in U.S. regulatory strategy, submissions, and compliance for medicinal products, with a strong understanding of drug development pathways and regulatory principles. Capable of effective communication and collaboration across global teams to ensure alignment and successful execution of regulatory activities.

Highest-signal resume keywords

Regulatory Submissions ExperienceFDA Interaction ExperienceU.S. Legislation KnowledgeDrug Development UnderstandingStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentClinical Trial AuthorizationMarketing Application ApprovalRegulatory Compliance ManagementLabeling Development SupportRisk AssessmentContingency PlanningScientific Data AnalysisRegulatory Intelligence ApplicationU.S. Registration Pathway Knowledge

Soft Skills

Conflict ResolutionInfluencing Without AuthorityCultural AwarenessTeam AlignmentProactive Issue Anticipation

Industry Keywords

Medicinal ProductsGeneral MedicineMetabolic DisordersEndocrinologyCardiovascular DiseasesPediatric PlansExpedited ProgramsCompassionate UseHealth Authority InteractionsGlobal Regulatory Strategy

About the role

Key responsibilities & impact

Execute U.S. regulatory strategy and deliverables for assigned programs and represent the region on global teams.
Plan and manage U.S. regulatory submissions (e.g., clinical trial and marketing applications) aligned with global filing plans and U.S. regulatory requirements.
Implement product-related regulatory tactics and activity plans in accordance with U.S. legislation, regulations, and internal standards.
Provide content guidance for key U.S. regulatory documents and meetings consistent with Global Regulatory strategy (e.g., briefing content, submission components).
Support U.S. labeling development in collaboration with the Labeling Working Group (LWG), incorporating scientific data, guidance, and precedent; support U.S. labeling negotiation activities.
Provide regulatory guidance on U.S. mechanisms and pathways to optimize development (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use where applicable).
Obtain and maintain clinical trial authorizations and marketing application approvals, including support for Responses to Questions (RTQs) and other agency feedback.
Communicate regulatory strategy and expectations within the team (e.g., GRT, affiliates/stakeholders) and work with line management to assess likelihood of success, expectations, and risks.
Ensure ongoing regulatory compliance for assigned products (e.g., IMR accuracy, PMCs/commitments, pediatric and other agency obligations); escalate issues proactively.
Maintain and apply U.S. regulatory intelligence: monitor evolving legislation/guidance; research precedent and history; assess and communicate potential impact (including competitor labeling where relevant).
Support Health Authority interactions by acting as an agency contact as appropriate, documenting outcomes, and contributing to risk/contingency planning consistent with global strategy.
Partner with cross-functional teams to support alignment and execution, including U.S.-specific considerations for data use in product communications (as applicable).

Requirements

What you’ll need

Doctorate degree OR Master’s degree and 2 years of directly related experience OR Bachelor’s degree and 4 years of directly related experience OR Associate’s degree and 8 years of directly related experience OR High school diploma / GED and 10 years of directly related experience.
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
Understanding of drug development and the U.S. registration pathway (e.g., marketing applications, post-approval changes, extensions/renewals)
Experience supporting regulatory strategy for programs in general medicine, metabolic disorders, endocrinology, or related therapeutic areas.
Foundational scientific understanding of cardiovascular and metabolic diseases
Strong written and oral communication skills; ability to communicate scientific/clinical information clearly
Ability to anticipate issues, evaluate risks, and contribute to practical contingency planning
Ability to resolve conflicts, influence without authority, and drive alignment across teams
Cultural awareness and ability to operate effectively across global/regional teams.

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.