US Regulatory Lead

🕒 Setembro 25

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $112.744 - $152.536 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 0%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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