Global Regulatory Submission Planning Sr. Manager – Obesity

🕒 Junho 3

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $142.579 - $192.901 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Biotechnology • Pharmaceuticals • Science

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

• Serve as the regulatory product planning lead for a key obesity asset, maintaining an integrated view of regulatory priorities, milestones, dependencies, and risks across multiple indications. • Develop and maintain a comprehensive Regulatory Product Plan that aligns regulatory objectives and activities, health authority interactions, development milestones, and major business priorities. • Partner with Global Regulatory Leads (GRLs), regional regulatory leads, and regulatory functional representatives to drive alignment on key deliverables, timelines, risks, and execution strategies. • Establish and maintain visibility into critical regulatory milestones, ensuring leadership has a clear understanding of readiness, risks, dependencies, and potential impacts to regulatory objectives. • Facilitate regulatory planning forums to support decision-making, issue resolution, and proactive management of emerging regulatory challenges.

🎯 Requisitos

• Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience • a minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. • Experience supporting global regulatory activities within obesity, cardiometabolic, or related therapeutic areas. • Strong understanding of global drug development and regulatory processes, including major regulatory milestones, health authority interactions, and submission requirements across key regions. • Demonstrated understanding of end-to-end product development and commercialization processes and the interdependencies that influence regulatory execution. • Experience developing and maintaining integrated plans within complex, matrixed organizations. • Demonstrated ability to coordinate and align activities across multiple indications, functions, regions, and stakeholders. • Excellent organizational skills with a proven ability to manage multiple priorities in a fast-paced environment.

🏖️ Benefícios

• 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.