Global Regulatory Affairs Director – Inflammation and Rare Disease

🕒 Setembro 29

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $189.632 - $256.561 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

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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

• Develop and execute the global regulatory product strategy • Lead Global Regulatory Teams (GRTs) • Represent Regulatory on the product team and key commercialization governance bodies • Develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan • Identify and communicate regulatory risks • Develop registration strategies and plans for regulatory approval and product labeling • Provide regulatory direction in development of the core data sheet • Lead planning and implementation of global regulatory filings, including clinical trial applications, marketing applications, label extensions, and CMC changes • Ensure consistency of evidence-based global product communication and regulatory submission documents • Monitor and assess relevant global regulations, guidance, and the regulatory environment • Assess and incorporate regulatory mechanisms such as FIH studies, Orphan Drug, Fast Track, conditional/accelerated approval, compassionate use, and pediatric plans • Communicate regulatory strategies throughout the organization • Lead core regulatory and cross-functional teams for effective regulatory agency communications • Attend key regulatory agency meetings affecting global product strategy • Represent Amgen Regulatory on external partnership teams at the product level

🎯 Requisitos

• Doctorate degree and 4 years of regulatory experience in biotech or science • Or Master’s degree and 7 years of regulatory experience in biotech or science • Or Bachelor’s degree and 9 years of regulatory experience in biotech or science • Ability to lead and build effective teams • Strong communication skills - both oral and written • Ability to understand and communicate scientific/clinical information • Ability to anticipate and mitigate against future strategic issues & uncertainties • Ability to resolve conflicts and develop a course of action • Cultural awareness and sensitivity to achieve global results • Planning and organizing abilities • Able to prioritize and manage multiple activities • Ability to make complex decisions and solve problems • Ability to deal with ambiguity • Negotiation skills

🏖️ 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 • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance